Endoscopic Metabolic and Bariatric Therapies

NCT05725967 | Enrolling By Invitation

• 1 other identifier: 2022P001757
• Study Type: observational
• Target: 5,000
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective collection of data from adult patients who have had an endoscopic metabolic and bariatric endoscopy procedure (EMBT) for primary or revision surgical procedures for obesity.

Conditions

Obesity; Obesity, Morbid; Obesity Associated Disorder; Bariatric Surgery Candidate; Fistula, Gastric; Roux-en-y Anastomosis Site; Ulcer, Gastric; Abdominal Pain; Abdominal Obesity; Complication of Surgical Procedure; Complication of Treatment; Complication,Postoperative; Weight Gain; Weight Loss; Leak, Anastomotic; Delayed Gastric Emptying Following Procedure

Keywords

Roux-en-Y Gastric Bypass; Sleeve Gastrectomy; laparoscopic adjustable gastric banding; gastroplasty with endoscopic myotomy (GEM); endoscopic sleeve gastroplasty (ESG); transoral outlet reduction (TORe); primary obesity surgery endoluminal (POSE); restorative obesity surgery endoluminal (ROSE); intragastric balloons (IGB); aspiration therapy; pylorus sparing antral myotomy (PSAM); gastric emptying breath test (GEBT)

Outcome Measures

Primary Outcomes (13)

• Change in weight from pre-procedure to 10 years

  %TBWL

  Baseline, 3 months, 6 months, 9 months, 12 months, years 1-10.

• Change in hypertension from pre-procedure to 10 years using blood pressure measurements

  Change of hypertension status by comparing blood pressure measurements (systolic/diastolic mmHg) from baseline.

  Baseline, 3 months, 6 months, 9 months, 12 months, years 1-10.

• Change in hypertension from pre-procedure to 10 years using medication dosages

  Change of hypertension status by comparing change in dosage (mg) of hypertension medications from baseline.

  Baseline, 3 months, 6 months, 9 months, 12 months, years 1-10.

• Change in medication dosage to determine change in diabetes status from pre-procedure to 10 years

  Change of diabetes status by comparing change in dosage (mg) of diabetes medications from baseline to 10 years.

  Baseline, 3 months, 6 months, 9 months, 12 months, years 1-10.

• Change percent value of HgA1c to determine change in diabetes status from pre-procedure to 10 years

  Change of HgA1c (%) by comparing lab values from baseline through 10 years.

  Baseline, 3 months, 6 months, 9 months, 12 months, years 1-10.

• Change in total cholesterol lab values (mg/dL) from pre-procedure to 10 years

  Change in total cholesterol measurements by comparing followup lab values (mg/dL) to baseline.

  Baseline, 3 months, 6 months, 9 months, 12 months, years 1-10.

• Change in low density lipoprotein (LDL) lab values (mg/dL) from pre-procedure to 10 years

  Change in LDL measurements by comparing followup lab values (mg/dL) to baseline.

  Baseline, 3 months, 6 months, 9 months, 12 months, years 1-10.

• Change in high density lipoprotein (HDL) lab values (mg/dL) from pre-procedure to 10 years

  Change in HDL measurements by comparing followup lab values (mg/dL) to baseline.

  Baseline, 3 months, 6 months, 9 months, 12 months, years 1-10.

• Change in medication dosage (mg) to determine change in total cholesterol (mg/dL) from pre-procedure to 10 years

  Change in total cholesterol measurements by comparing change in dosage of cholesterol medications (mg) from baseline to 10 years.

  Baseline, 3 months, 6 months, 9 months, 12 months, years 1-10.

• Change in medication dosage (mg) to determine change in High Density Lipoprotein (HDL) (mg/dL) from pre-procedure to 10 years

  Change in HDL measurements by comparing change in dosage of cholesterol medications (mg) from baseline to 10 years.

  Baseline, 3 months, 6 months, 9 months, 12 months, years 1-10.

• Change in medication dosage (mg) to determine change in Low Density Lipoprotein (LDL) (mg/dL) from pre-procedure to 10 years

  Change in LDL measurements by comparing change in dosage of cholesterol medications (mg) from baseline to 10 years.

  Baseline, 3 months, 6 months, 9 months, 12 months, years 1-10.

• Change in rate of adverse events from procedure to 10 years

  Change in rate of adverse events post-procedure through 10 years

  Procedure, 1 month, 3 months, 6 months, 9 months, 12 months, years 1-10.

• Change in comorbidity medication dosages from baseline to 10 years

  Change of dosage of comorbidity medications compared to baseline

  Baseline, 1 month, 3 months, 6 months, 9 months, 12 months, years 1-10.

Secondary Outcomes (5)

• Change in gastric motility from baseline to 10 years

  Baseline, 1 month, 3 months, 6 months, 9 months, 12 months, years 1-10.

• Change in PYY gut hormones from baseline to 10 years

  Baseline, 1 month, 3 months, 6 months, 9 months, 12 months, years 1-10.

• Change in GLP1 gut hormones from baseline to 10 years

  Baseline, 1 month, 3 months, 6 months, 9 months, 12 months, years 1-10.

• Change in ghrelin hormones from baseline to 10 years

  Baseline, 1 month, 3 months, 6 months, 9 months, 12 months, years 1-10.

• Cost comparison of procedural costs associated with bariatric endoscopic vs. surgical procedures from baseline to 10 years

  Pre-intervention/procedure/surgery, during the procedure/surgery, immediately after the intervention/procedure/surgery, up to 3 months after the intervention/procedure/surgery

Study Arms (3)

Primary Obesity Endoscopic Procedures

Primary endoscopic procedures for treatment of obesity.

Procedure: Primary Obesity Endoscopic Procedures; Device: Endoscopic Sleeve Gastroplasty, Trans-oral Outlet Reduction; Device: Intragastric Balloon; Device: Primary obesity surgery endoluminal, Restorative obesity surgery endoluminal; Device: Argon Plasma Coagulation, Gastroplasty with Endoscopic Myotomy, Bariatric Endoscopic Antral Myotomy, Pylorus Sparing Antral Myotomy; Device: Aspiration Therapy

Endoscopic Revision of Bariatric Surgical Procedures

Endoscopic revision of post-bariatric surgical complications.

Procedure: Endoscopic Revision of Bariatric Surgical Procedures; Device: Endoscopic Sleeve Gastroplasty, Trans-oral Outlet Reduction; Device: Primary obesity surgery endoluminal, Restorative obesity surgery endoluminal; Device: Argon Plasma Coagulation, Gastroplasty with Endoscopic Myotomy, Bariatric Endoscopic Antral Myotomy, Pylorus Sparing Antral Myotomy

Bariatric Surgery Procedures

Bariatric surgical procedures.

Procedure: Bariatric Surgery Procedures

Interventions

Primary Obesity Endoscopic Procedures PROCEDURE

Any primary endoscopic procedure for treatment of obesity including endoscopic sleeve gastroplasty (ESG), intragastric balloons (IGB), Aspiration therapy, pylorus sparing antral myotomy (PSAM), primary obesity surgery endoluminal (POSE), gastroplasty with endoscopic myotomy (GEM).

Also known as: ESG, Aspiration Therapy, IGB, POSE, GEM, PSAM, BEAM, EMBTs

Primary Obesity Endoscopic Procedures

Endoscopic Revision of Bariatric Surgical Procedures PROCEDURE

Any endoscopic revision procedure in a post-bariatric surgical patient, including transoral outlet reduction (TORe), restorative obesity surgery endoluminal (ROSE), argon plasma coagulation of the outlet (APC), endoscopic suturing.

Also known as: TORe, ROSE, APC

Endoscopic Revision of Bariatric Surgical Procedures

Bariatric Surgery Procedures PROCEDURE

Any bariatric surgical procedure including Roux-en-Y gastric bypass (RYGB), laparoscopic sleeve gastroplasty (LSG), laparoscopic adjustable gastric banding (LAGB)

Also known as: RYGB, LSG, LAGB

Bariatric Surgery Procedures

Endoscopic Sleeve Gastroplasty, Trans-oral Outlet Reduction DEVICE

Any endoscopic procedure using an endoscopic suturing device for primary obesity treatment or revision of post bariatric complications.

Also known as: ESG, TORe

Endoscopic Revision of Bariatric Surgical Procedures; Primary Obesity Endoscopic Procedures

Intragastric Balloon DEVICE

An endoscopic bariatric procedure involving the placement of an intragastric balloon.

Also known as: IGB

Primary Obesity Endoscopic Procedures

Primary obesity surgery endoluminal, Restorative obesity surgery endoluminal DEVICE

Any endoscopic procedure using an endoscopic plicating device for primary obesity treatment or revision of post bariatric complications.

Also known as: POSE, ROSE

Endoscopic Revision of Bariatric Surgical Procedures; Primary Obesity Endoscopic Procedures

Argon Plasma Coagulation, Gastroplasty with Endoscopic Myotomy, Bariatric Endoscopic Antral Myotomy, Pylorus Sparing Antral Myotomy DEVICE

Electrosurgical interventions for obesity. Use of electrosurgical devices, such as electrocautery for the primary treatment of obesity or obesity related complications.

Also known as: APC, GEM, BEAM, PSAM

Endoscopic Revision of Bariatric Surgical Procedures; Primary Obesity Endoscopic Procedures

Aspiration Therapy DEVICE

Placement of an aspiration therapy device for the treatment of obesity.

Also known as: Aspire

Primary Obesity Endoscopic Procedures

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients registered with Mass General Brigham affiliate facilities who have undergone an endoscopic primary obesity procedure, an endoscopic bariatric revision procedure, or a bariatric surgical procedure.

You may qualify if:

• patients from Mass General Brigham
• any patient having an endoscopic primary obesity procedure
• any patient having an endoscopic post-bariatric surgical revision procedure
• any patient having a bariatric surgical procedure

You may not qualify if:

• patients without past surgical and medical history medical records in the Mass General Brigham system
• patients unwilling to allow for medical record review at Mass General Brigham

Sponsors & Collaborators

• Christopher C. Thompson, MD, MSc: lead

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Related Publications (12)

• 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

• Jirapinyo P, Thompson CC. Endoscopic gastric plication for the treatment of weight regain after Roux-en-Y gastric bypass (with video). Gastrointest Endosc. 2022 Jul;96(1):51-56. doi: 10.1016/j.gie.2022.02.051. Epub 2022 Mar 5.

  PMID: 35259393 BACKGROUND

• de Moura DTH, Hirsch BS, Boghossian MB, de Medeiros FS, McCarty TR, Thompson CC, de Moura EGH. Low-cost modified endoscopic vacuum therapy using a triple-lumen tube allows nutrition and drainage for treatment of an early post-bariatric surgery leak. Endoscopy. 2022 Jul;54(7):E376-E377. doi: 10.1055/a-1540-5870. Epub 2021 Aug 9. No abstract available.

  PMID: 34374043 BACKGROUND

• de Moura DTH, de Freitas Junior JR, de Souza GMV, de Oliveira GHP, McCarty TR, Thompson CC, de Moura EGH. Endoscopic management of acute leak after sleeve gastrectomy: principles and techniques. Endoscopy. 2022 Jul;54(7):E327-E328. doi: 10.1055/a-1525-1661. Epub 2021 Jul 9. No abstract available.

  PMID: 34243196 BACKGROUND

• Sanchez-Luna SA, Thompson CC, De Moura EGH, de Medeiros FS, De Moura DTH. Modified endoscopic vacuum therapy: Are we ready for prime time? Gastrointest Endosc. 2022 Jun;95(6):1281-1282. doi: 10.1016/j.gie.2021.12.049. No abstract available.

  PMID: 35589208 BACKGROUND

• Bazarbashi AN, Dolan RD, McCarty TR, Jirapinyo P, Thompson CC. Endoscopic revision of gastrojejunal anastomosis for the treatment of dumping syndrome in patients with Roux-en-Y gastric bypass: a systematic review and meta-analysis. Surg Endosc. 2022 Jun;36(6):4099-4107. doi: 10.1007/s00464-021-08731-4. Epub 2021 Oct 20.

  PMID: 34669046 BACKGROUND

• Jirapinyo P, Thompson CC. Primary Bariatric Procedures. Dig Dis Sci. 2022 May;67(5):1674-1687. doi: 10.1007/s10620-022-07393-z. Epub 2022 Mar 29.

  PMID: 35348970 BACKGROUND

• Argueta PP, Salazar M, Vargo JJ, Chahal P, Rodriguez JJ, Simons-Linares CR, Thompson CC. Thirty-Day Readmission After Bariatric Surgery: Causes, Effects on Outcomes, and Predictors. Dig Dis Sci. 2022 Mar;67(3):834-843. doi: 10.1007/s10620-021-06934-2. Epub 2021 Jun 24.

  PMID: 34169433 BACKGROUND

• Jirapinyo P, McCarty TR, Dolan RD, Shah R, Thompson CC. Effect of Endoscopic Bariatric and Metabolic Therapies on Nonalcoholic Fatty Liver Disease: A Systematic Review and Meta-analysis. Clin Gastroenterol Hepatol. 2022 Mar;20(3):511-524.e1. doi: 10.1016/j.cgh.2021.03.017. Epub 2021 Mar 13.

  PMID: 33727164 BACKGROUND

• Singh S, Bazarbashi AN, Khan A, Chowdhry M, Bilal M, de Moura DTH, Jirapinyo P, Thakkar S, Thompson CC. Primary obesity surgery endoluminal (POSE) for the treatment of obesity: a systematic review and meta-analysis. Surg Endosc. 2022 Jan;36(1):252-266. doi: 10.1007/s00464-020-08267-z. Epub 2021 Feb 1.

  PMID: 33523277 BACKGROUND

• Thompson CC, Jirapinyo P, Shah R, Simsek C. Gastroplasty With Endoscopic Myotomy (GEM) for the Treatment of Obesity: Preliminary Efficacy and Physiologic Results. Gastroenterology. 2022 Nov;163(5):1173-1175. doi: 10.1053/j.gastro.2022.07.077. Epub 2022 Aug 10. No abstract available.

  PMID: 35961376 RESULT

• Jirapinyo P, Thompson CC. Comparison of distal primary obesity surgery endolumenal techniques for the treatment of obesity (with videos). Gastrointest Endosc. 2022 Sep;96(3):479-486. doi: 10.1016/j.gie.2022.04.1346. Epub 2022 May 11.

  PMID: 35568242 RESULT

MeSH Terms

Conditions

Obesity; Obesity, Morbid; Gastric Fistula; Stomach Ulcer; Abdominal Pain; Obesity, Abdominal; Postoperative Complications; Weight Gain; Weight Loss; Anastomotic Leak

Interventions

immunoglobulin B; Bariatric Surgery; Argon Plasma Coagulation; Gastroplasty

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Digestive System Fistula; Digestive System Diseases; Fistula; Pathological Conditions, Anatomical; Peptic Ulcer; Duodenal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Stomach Diseases; Pain; Neurologic Manifestations; Signs and Symptoms, Digestive; Pathologic Processes; Body Weight Changes

Intervention Hierarchy (Ancestors)

Bariatrics; Obesity Management; Therapeutics; Surgical Procedures, Operative; Electrocoagulation; Cautery; Hemostatic Techniques; Ablation Techniques; Hemostasis, Surgical; Digestive System Surgical Procedures

Study Officials

• Christopher C. Thompson, MD, MSc

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director of Endoscopy

Study Record Dates

• First Submitted: December 29, 2022
• First Posted: February 13, 2023
• Study Start: July 8, 2022
• Primary Completion (Estimated): May 28, 2028
• Study Completion (Estimated): May 28, 2029
• Last Updated: December 2, 2025

Record last verified: 2025-11

Locations

US (1)