Effect of Endoscopic Sleeve Gastroplasty in Patients With Obesity and MASH: A Randomized Controlled Trial

NCT06138821 | Recruiting FDA Device

• 1 other identifier: 2024P002282
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 2

Brief Summary

Metabolic dysfunction-associated steatotic liver disease (MASLD) is the most common chronic liver disease globally. While weight loss through lifestyle modification is the standard treatment, most patients regain weight limiting ultimate improvement in liver disease. On the other end of the spectrum, bariatric surgery has shown promise in the treatment of MASLD/metabolic dysfunction-associated steatohepatitis (MASH) due to its efficacy in inducing weight loss. Nevertheless, its adoption has been hindered by the perceived invasiveness of surgery. Over the past decade, endoscopic sleeve gastroplasty (ESG) has gained recognition as a promising minimally-invasive approach to weight loss. The procedure involves utilizing a Food and Drug Administration (FDA)-authorized endoscopic suturing device to reduce the gastric volume by 70%. Studies reveal that ESG is associated with approximately 18.2% weight loss at one year after the procedure, with sustained results for at least 10 years. Nevertheless, the effect of ESG on MASH remains unknown. In this study, the investigators will compare ESG + lifestyle modification versus lifestyle modification alone in treating histologic MASH. The study will randomize patients to one of two different treatment options: ESG + lifestyle modification or lifestyle modification alone.

Conditions

Obesity; Liver Diseases; Liver Fibrosis; Liver Fat; Metabolic Dysfunction-Associated Steatotic Liver Disease; Metabolic Dysfunction-Associated Steatohepatitis; MASLD; MASH; Weight Loss; Insulin Resistance; Insulin Sensitivity; Insulin Sensitivity/Resistance; Metabolic Disease; Diabetes; Diabetes Mellitus, Type 2; NASH With Fibrosis; Non-Alcoholic Fatty Liver Disease; Non Alcoholic Fatty Liver; Non-alcoholic Steatohepatitis

Keywords

Gut Hormones; Endoscopic Bariatric and Metabolic Therapy (EBMT); Intragastric Balloon (IGB); Endoscopic Suturing; Endoscopic Sleeve Gastroplasty (ESG); Weight Management; Endoscopic Gastric Remodeling (EGR); Endoscopic Bariatric Therapy (EBT); Fatty Liver; Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD); Metabolic Dysfunction-Associated Steatohepatitis (MASH); Non-Alcoholic Fatty Liver Disease (NAFLD); Non-Alcoholic Steatohepatitis (NASH)

Outcome Measures

Primary Outcomes (1)

• MASH resolution without worsening of liver fibrosis at 12 months

  Comparison of endoscopic ultrasound (EUS)-guided liver biopsy results to assess MASH resolution at 12 months compared to baseline in the ESG + lifestyle modification (LM) group compared to LM alone group.

  Baseline, 12 months

Secondary Outcomes (17)

• An improvement of liver fibrosis by at least one stage without worsening of MASH at 12 months

  Baseline, 12 months

• Change in liver stiffness on MRE at 12 months

  Baseline, 12 months

• Change in liver stiffness on VCTE at 12 months

  Baseline, 12 months

• Change in liver fibrosis using NFS at 12 months

  Baseline, 12 months

• Change in liver fibrosis using ELF score at 12 months

  Baseline, 12 months

Study Arms (2)

ESG + lifestyle modification

EXPERIMENTAL

Endoscopic sleeve gastroplasty weight loss procedure with a lifestyle modification program for 12 months.

Device: ESG + lifestyle modification; Behavioral: Lifestyle modification

Lifestyle modification

ACTIVE COMPARATOR

Lifestyle modification program for 12 months.

Behavioral: Lifestyle modification

Interventions

ESG + lifestyle modification DEVICE

Endoscopic sleeve gastroplasty - an endoscopic weight loss procedure where an endoscopic suturing device is utilized to reduce the size of the stomach by 70%.

Also known as: Endoscopic sleeve gastroplasty, Endoscopic suturing

ESG + lifestyle modification

Lifestyle modification BEHAVIORAL

Lifestyle modification program consisting of diet and exercise therapy

ESG + lifestyle modification; Lifestyle modification

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 (male or female)
• BMI ≥30 kg/m2
• Self-reported stable weight (no weight change \>5%) for 6 months prior to the first study visit
• Willingness to follow protocol requirements, including signed informed consent, routine follow-up schedule, completing laboratory/imaging/additional tests, and completing diet counseling
• Willingness to NOT start a new anti-obesity medication for the following 12 months
• Residing within a reasonable distance from the investigator's office and able to travel to the investigator to complete routine follow-up visits
• Ability to give informed consent
• Women of childbearing potential (i.e., not post-menopausal, nor surgically sterilized) must agree to use adequate birth control methods

You may not qualify if:

• Known history of other chronic liver diseases (viral hepatitis, autoimmune hepatitis, drug-induced hepatitis, and genetic)
• Treatment with vitamin E (at doses ≥800 IU/day), pioglitazone, obeticholic acid, or resmetirom \<90 days before the first study visit
• History of foregut or gastrointestinal (GI) surgery (except uncomplicated fundoplication, cholecystectomy or appendectomy)
• Prior bariatric surgery
• Prior endoscopic sleeve gastroplasty
• Any inflammatory disease of the GI tract, including severe (LA Grade C or D) esophagitis, Barrett's esophagus with dysplasia, gastric ulceration, duodenal ulceration, cancer or specific inflammation such as Crohn's disease
• Potential upper gastrointestinal bleeding conditions such as esophageal or gastric varices, congenital or acquired intestinal telangiectasis, or other congenital anomalies of the gastrointestinal tract such as atresias or stenoses
• Severe gastroesophageal reflux disease (GERD)
• A structural abnormality in the esophagus or pharynx, such as a stricture or diverticulum, that could impede passage of the endoscope.
• Achalasia or any other severe esophageal motility disorder
• Chronic abdominal pain
• Gastroparesis or intractable constipation
• Hepatic insufficiency or cirrhosis
• Severe coagulopathy
• Insulin-dependent diabetes (either type 1 or type 2) or a significant likelihood of requiring insulin treatment in the following 12 months or HgbA1C ≥ 10%

Sponsors & Collaborators

• Pichamol Jirapinyo, MD, MPH: lead
• Boston Scientific Corporation: collaborator
• Cook Group Incorporated: collaborator

Study Sites (2)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

RECRUITING

West Virginia University

Morgantown, West Virginia, 26506, United States

RECRUITING

Related Publications (28)

• Flegal KM, Carroll MD, Ogden CL, Curtin LR. Prevalence and trends in obesity among US adults, 1999-2008. JAMA. 2010 Jan 20;303(3):235-41. doi: 10.1001/jama.2009.2014. Epub 2010 Jan 13.

  PMID: 20071471 BACKGROUND

• Flegal KM, Kit BK, Orpana H, Graubard BI. Association of all-cause mortality with overweight and obesity using standard body mass index categories: a systematic review and meta-analysis. JAMA. 2013 Jan 2;309(1):71-82. doi: 10.1001/jama.2012.113905.

  PMID: 23280227 BACKGROUND

• Adams KF, Schatzkin A, Harris TB, Kipnis V, Mouw T, Ballard-Barbash R, Hollenbeck A, Leitzmann MF. Overweight, obesity, and mortality in a large prospective cohort of persons 50 to 71 years old. N Engl J Med. 2006 Aug 24;355(8):763-78. doi: 10.1056/NEJMoa055643. Epub 2006 Aug 22.

  PMID: 16926275 BACKGROUND

• Prospective Studies Collaboration; Whitlock G, Lewington S, Sherliker P, Clarke R, Emberson J, Halsey J, Qizilbash N, Collins R, Peto R. Body-mass index and cause-specific mortality in 900 000 adults: collaborative analyses of 57 prospective studies. Lancet. 2009 Mar 28;373(9669):1083-96. doi: 10.1016/S0140-6736(09)60318-4. Epub 2009 Mar 18.

  PMID: 19299006 BACKGROUND

• Finkelstein EA, Trogdon JG, Cohen JW, Dietz W. Annual medical spending attributable to obesity: payer-and service-specific estimates. Health Aff (Millwood). 2009 Sep-Oct;28(5):w822-31. doi: 10.1377/hlthaff.28.5.w822. Epub 2009 Jul 27.

  PMID: 19635784 BACKGROUND

• Cawley J, Meyerhoefer C. The medical care costs of obesity: an instrumental variables approach. J Health Econ. 2012 Jan;31(1):219-30. doi: 10.1016/j.jhealeco.2011.10.003. Epub 2011 Oct 20.

  PMID: 22094013 BACKGROUND

• Jensen MD, Ryan DH, Apovian CM, Ard JD, Comuzzie AG, Donato KA, Hu FB, Hubbard VS, Jakicic JM, Kushner RF, Loria CM, Millen BE, Nonas CA, Pi-Sunyer FX, Stevens J, Stevens VJ, Wadden TA, Wolfe BM, Yanovski SZ; American College of Cardiology/American Heart Association Task Force on Practice Guidelines; Obesity Society. 2013 AHA/ACC/TOS guideline for the management of overweight and obesity in adults: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines and The Obesity Society. J Am Coll Cardiol. 2014 Jul 1;63(25 Pt B):2985-3023. doi: 10.1016/j.jacc.2013.11.004. Epub 2013 Nov 12. No abstract available.

  PMID: 24239920 BACKGROUND

• Stevens VJ, Obarzanek E, Cook NR, Lee IM, Appel LJ, Smith West D, Milas NC, Mattfeldt-Beman M, Belden L, Bragg C, Millstone M, Raczynski J, Brewer A, Singh B, Cohen J; Trials for the Hypertension Prevention Research Group. Long-term weight loss and changes in blood pressure: results of the Trials of Hypertension Prevention, phase II. Ann Intern Med. 2001 Jan 2;134(1):1-11. doi: 10.7326/0003-4819-134-1-200101020-00007.

  PMID: 11187414 BACKGROUND

• Gregg EW, Chen H, Wagenknecht LE, Clark JM, Delahanty LM, Bantle J, Pownall HJ, Johnson KC, Safford MM, Kitabchi AE, Pi-Sunyer FX, Wing RR, Bertoni AG; Look AHEAD Research Group. Association of an intensive lifestyle intervention with remission of type 2 diabetes. JAMA. 2012 Dec 19;308(23):2489-96. doi: 10.1001/jama.2012.67929.

  PMID: 23288372 BACKGROUND

• Look AHEAD Research Group; Pi-Sunyer X, Blackburn G, Brancati FL, Bray GA, Bright R, Clark JM, Curtis JM, Espeland MA, Foreyt JP, Graves K, Haffner SM, Harrison B, Hill JO, Horton ES, Jakicic J, Jeffery RW, Johnson KC, Kahn S, Kelley DE, Kitabchi AE, Knowler WC, Lewis CE, Maschak-Carey BJ, Montgomery B, Nathan DM, Patricio J, Peters A, Redmon JB, Reeves RS, Ryan DH, Safford M, Van Dorsten B, Wadden TA, Wagenknecht L, Wesche-Thobaben J, Wing RR, Yanovski SZ. Reduction in weight and cardiovascular disease risk factors in individuals with type 2 diabetes: one-year results of the look AHEAD trial. Diabetes Care. 2007 Jun;30(6):1374-83. doi: 10.2337/dc07-0048. Epub 2007 Mar 15.

  PMID: 17363746 BACKGROUND

• Yanovski SZ, Yanovski JA. Long-term drug treatment for obesity: a systematic and clinical review. JAMA. 2014 Jan 1;311(1):74-86. doi: 10.1001/jama.2013.281361.

  PMID: 24231879 BACKGROUND

• Wing RR, Lang W, Wadden TA, Safford M, Knowler WC, Bertoni AG, Hill JO, Brancati FL, Peters A, Wagenknecht L; Look AHEAD Research Group. Benefits of modest weight loss in improving cardiovascular risk factors in overweight and obese individuals with type 2 diabetes. Diabetes Care. 2011 Jul;34(7):1481-6. doi: 10.2337/dc10-2415. Epub 2011 May 18.

  PMID: 21593294 BACKGROUND

• Buchwald H, Oien DM. Metabolic/bariatric surgery worldwide 2011. Obes Surg. 2013 Apr;23(4):427-36. doi: 10.1007/s11695-012-0864-0.

  PMID: 23338049 BACKGROUND

• GBD 2015 Obesity Collaborators; Afshin A, Forouzanfar MH, Reitsma MB, Sur P, Estep K, Lee A, Marczak L, Mokdad AH, Moradi-Lakeh M, Naghavi M, Salama JS, Vos T, Abate KH, Abbafati C, Ahmed MB, Al-Aly Z, Alkerwi A, Al-Raddadi R, Amare AT, Amberbir A, Amegah AK, Amini E, Amrock SM, Anjana RM, Arnlov J, Asayesh H, Banerjee A, Barac A, Baye E, Bennett DA, Beyene AS, Biadgilign S, Biryukov S, Bjertness E, Boneya DJ, Campos-Nonato I, Carrero JJ, Cecilio P, Cercy K, Ciobanu LG, Cornaby L, Damtew SA, Dandona L, Dandona R, Dharmaratne SD, Duncan BB, Eshrati B, Esteghamati A, Feigin VL, Fernandes JC, Furst T, Gebrehiwot TT, Gold A, Gona PN, Goto A, Habtewold TD, Hadush KT, Hafezi-Nejad N, Hay SI, Horino M, Islami F, Kamal R, Kasaeian A, Katikireddi SV, Kengne AP, Kesavachandran CN, Khader YS, Khang YH, Khubchandani J, Kim D, Kim YJ, Kinfu Y, Kosen S, Ku T, Defo BK, Kumar GA, Larson HJ, Leinsalu M, Liang X, Lim SS, Liu P, Lopez AD, Lozano R, Majeed A, Malekzadeh R, Malta DC, Mazidi M, McAlinden C, McGarvey ST, Mengistu DT, Mensah GA, Mensink GBM, Mezgebe HB, Mirrakhimov EM, Mueller UO, Noubiap JJ, Obermeyer CM, Ogbo FA, Owolabi MO, Patton GC, Pourmalek F, Qorbani M, Rafay A, Rai RK, Ranabhat CL, Reinig N, Safiri S, Salomon JA, Sanabria JR, Santos IS, Sartorius B, Sawhney M, Schmidhuber J, Schutte AE, Schmidt MI, Sepanlou SG, Shamsizadeh M, Sheikhbahaei S, Shin MJ, Shiri R, Shiue I, Roba HS, Silva DAS, Silverberg JI, Singh JA, Stranges S, Swaminathan S, Tabares-Seisdedos R, Tadese F, Tedla BA, Tegegne BS, Terkawi AS, Thakur JS, Tonelli M, Topor-Madry R, Tyrovolas S, Ukwaja KN, Uthman OA, Vaezghasemi M, Vasankari T, Vlassov VV, Vollset SE, Weiderpass E, Werdecker A, Wesana J, Westerman R, Yano Y, Yonemoto N, Yonga G, Zaidi Z, Zenebe ZM, Zipkin B, Murray CJL. Health Effects of Overweight and Obesity in 195 Countries over 25 Years. N Engl J Med. 2017 Jul 6;377(1):13-27. doi: 10.1056/NEJMoa1614362. Epub 2017 Jun 12.

  PMID: 28604169 BACKGROUND

• ASGE Bariatric Endoscopy Task Force; Sullivan S, Kumar N, Edmundowicz SA, Abu Dayyeh BK, Jonnalagadda SS, Larsen M, Thompson CC. ASGE position statement on endoscopic bariatric therapies in clinical practice. Gastrointest Endosc. 2015 Nov;82(5):767-72. doi: 10.1016/j.gie.2015.06.038. Epub 2015 Aug 15. No abstract available.

  PMID: 26282949 BACKGROUND

• Mahapatra MK, Karuppasamy M, Sahoo BM. Therapeutic Potential of Semaglutide, a Newer GLP-1 Receptor Agonist, in Abating Obesity, Non-Alcoholic Steatohepatitis and Neurodegenerative diseases: A Narrative Review. Pharm Res. 2022 Jun;39(6):1233-1248. doi: 10.1007/s11095-022-03302-1. Epub 2022 Jun 1.

  PMID: 35650449 BACKGROUND

• Abu Dayyeh BK, Rajan E, Gostout CJ. Endoscopic sleeve gastroplasty: a potential endoscopic alternative to surgical sleeve gastrectomy for treatment of obesity. Gastrointest Endosc. 2013 Sep;78(3):530-5. doi: 10.1016/j.gie.2013.04.197. Epub 2013 May 24.

  PMID: 23711556 BACKGROUND

• Sharaiha RZ, Kedia P, Kumta N, DeFilippis EM, Gaidhane M, Shukla A, Aronne LJ, Kahaleh M. Initial experience with endoscopic sleeve gastroplasty: technical success and reproducibility in the bariatric population. Endoscopy. 2015 Feb;47(2):164-6. doi: 10.1055/s-0034-1390773. Epub 2014 Nov 7.

  PMID: 25380510 BACKGROUND

• Lopez-Nava G, Galvao MP, da Bautista-Castano I, Jimenez A, De Grado T, Fernandez-Corbelle JP. Endoscopic sleeve gastroplasty for the treatment of obesity. Endoscopy. 2015 May;47(5):449-52. doi: 10.1055/s-0034-1390766. Epub 2014 Nov 7.

  PMID: 25380508 BACKGROUND

• Abu Dayyeh BK, Acosta A, Camilleri M, Mundi MS, Rajan E, Topazian MD, Gostout CJ. Endoscopic Sleeve Gastroplasty Alters Gastric Physiology and Induces Loss of Body Weight in Obese Individuals. Clin Gastroenterol Hepatol. 2017 Jan;15(1):37-43.e1. doi: 10.1016/j.cgh.2015.12.030. Epub 2015 Dec 31.

  PMID: 26748219 BACKGROUND

• ASGE/ASMBS Task Force on Endoscopic Bariatric Therapy; Ginsberg GG, Chand B, Cote GA, Dallal RM, Edmundowicz SA, Nguyen NT, Pryor A, Thompson CC. A pathway to endoscopic bariatric therapies. Gastrointest Endosc. 2011 Nov;74(5):943-53. doi: 10.1016/j.gie.2011.08.053. No abstract available.

  PMID: 22032311 BACKGROUND

• Mechanick JI, Youdim A, Jones DB, Timothy Garvey W, Hurley DL, Molly McMahon M, Heinberg LJ, Kushner R, Adams TD, Shikora S, Dixon JB, Brethauer S. Clinical practice guidelines for the perioperative nutritional, metabolic, and nonsurgical support of the bariatric surgery patient--2013 update: cosponsored by American Association of Clinical Endocrinologists, the Obesity Society, and American Society for Metabolic & Bariatric Surgery. Surg Obes Relat Dis. 2013 Mar-Apr;9(2):159-91. doi: 10.1016/j.soard.2012.12.010. Epub 2013 Jan 19.

  PMID: 23537696 BACKGROUND

• Abu Dayyeh BK, Bazerbachi F, Vargas EJ, Sharaiha RZ, Thompson CC, Thaemert BC, Teixeira AF, Chapman CG, Kumbhari V, Ujiki MB, Ahrens J, Day C; MERIT Study Group; Galvao Neto M, Zundel N, Wilson EB. Endoscopic sleeve gastroplasty for treatment of class 1 and 2 obesity (MERIT): a prospective, multicentre, randomised trial. Lancet. 2022 Aug 6;400(10350):441-451. doi: 10.1016/S0140-6736(22)01280-6. Epub 2022 Jul 28.

  PMID: 35908555 BACKGROUND

• Vilar-Gomez E, Martinez-Perez Y, Calzadilla-Bertot L, Torres-Gonzalez A, Gra-Oramas B, Gonzalez-Fabian L, Friedman SL, Diago M, Romero-Gomez M. Weight Loss Through Lifestyle Modification Significantly Reduces Features of Nonalcoholic Steatohepatitis. Gastroenterology. 2015 Aug;149(2):367-78.e5; quiz e14-5. doi: 10.1053/j.gastro.2015.04.005. Epub 2015 Apr 10.

  PMID: 25865049 BACKGROUND

• Harrison SA, Bedossa P, Guy CD, Schattenberg JM, Loomba R, Taub R, Labriola D, Moussa SE, Neff GW, Rinella ME, Anstee QM, Abdelmalek MF, Younossi Z, Baum SJ, Francque S, Charlton MR, Newsome PN, Lanthier N, Schiefke I, Mangia A, Pericas JM, Patil R, Sanyal AJ, Noureddin M, Bansal MB, Alkhouri N, Castera L, Rudraraju M, Ratziu V; MAESTRO-NASH Investigators. A Phase 3, Randomized, Controlled Trial of Resmetirom in NASH with Liver Fibrosis. N Engl J Med. 2024 Feb 8;390(6):497-509. doi: 10.1056/NEJMoa2309000.

  PMID: 38324483 BACKGROUND

• Jirapinyo P, Zucker SD, Thompson CC. Regression of Hepatic Fibrosis After Endoscopic Gastric Plication in Nonalcoholic Fatty Liver Disease. Am J Gastroenterol. 2023 Jun 1;118(6):983-990. doi: 10.14309/ajg.0000000000002087. Epub 2022 Dec 23.

  PMID: 36597405 BACKGROUND

• Jirapinyo P, Thompson CC, Garcia-Tsao G, Zucker SD, Ryou M. The effect of endoscopic gastric plication on portosystemic pressure gradient in patients with nonalcoholic fatty liver disease and compensated advanced chronic liver disease. Endoscopy. 2024 Jan;56(1):56-62. doi: 10.1055/a-2146-8857. Epub 2023 Aug 2.

  PMID: 37532114 BACKGROUND

• Jirapinyo P, Hadefi A, Thompson CC, Patai AV, Pannala R, Goelder SK, Kushnir V, Barthet M, Apovian CM, Boskoski I, Chapman CG, Davidson P, Donatelli G, Kumbhari V, Hayee B, Esker J, Hucl T, Pryor AD, Maselli R, Schulman AR, Pattou F, Zelber-Sagi S, Bain PA, Durieux V, Triantafyllou K, Thosani N, Huberty V, Sullivan S. American Society for Gastrointestinal Endoscopy-European Society of Gastrointestinal Endoscopy guideline on primary endoscopic bariatric and metabolic therapies for adults with obesity. Gastrointest Endosc. 2024 Jun;99(6):867-885.e64. doi: 10.1016/j.gie.2023.12.004. Epub 2024 Apr 19.

  PMID: 38639680 BACKGROUND

MeSH Terms

Conditions

Obesity; Liver Diseases; Liver Cirrhosis; Fatty Liver; Weight Loss; Insulin Resistance; Metabolic Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Digestive System Diseases; Fibrosis; Pathologic Processes; Body Weight Changes; Hyperinsulinism; Glucose Metabolism Disorders; Endocrine System Diseases

Study Officials

• Pichamol Jirapinyo, MD, MPH

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michele Research Manager, MS

CONTACT

6175258266; mryan@bwh.harvard.edu

Samantha Clinical Research Coordinator

CONTACT

617-732-5174; sgeltz@bwh.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director of Bariatric Endoscopy Fellowship

Model Details: This study is a randomized, controlled, open-label clinical trial.

Study Record Dates

• First Submitted: November 14, 2023
• First Posted: November 18, 2023
• Study Start: June 24, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): June 1, 2028
• Last Updated: December 2, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: 12 months after publication of study results. No end date.
• Access Criteria: Data will only be shared with a proper data transfer agreement in place between Brigham and Women's Hospital and the Institution of the requesting investigator.

Locations

US (2)