Hybrid Argon Plasma Coagulation and Endoscopic Sleeve Gastroplasty Validation Study

NCT05870943 | Active Not Recruiting

• 1 other identifier: RCT-001
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this research is to evaluate the clinical safety, durability, and weight loss outcomes of the hybrid argon plasma coagulation + endoscopic sleeve gastroplasty (HAPC-ESG) procedure when compared to traditional endoscopic sleeve gastroplasty (ESG) alone. ESG was proven to be feasible in human subjects in 2013 and since then has become the most commonly performed endoscopic bariatric remodeling procedure. However, this procedure may be enhanced with the addition of the hybrid argon plasma coagulation (HAPC) technique, leading to enhanced weight loss, durability, and metabolic benefits. Argon plasma coagulation (APC) is a method of non-contact thermal hemostasis initially created to assist in inducing hemostasis utilizing a high-frequency current to the targeted area. This is a validation study of a pilot randomized control trial which will evaluate the safety, durability, and effects on weight loss of the combined HAPC-ESG approach when compared to traditional ESG alone.

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

• Durability assessed by blinded physician(s) with expertise in endoscopic sleeve gastroplasty (ESG) procedures graded according to a priori standardized criteria.

  The primary outcomes are durability of plications and endoscopic sutures on repeat endoscopy at 6 months, in the two randomized arms. Durability of plications and endoscopic sutures will be assessed by blinded physician(s) with expertise in ESG who will assess sleeve-like anatomy (scale: None, Some, Typical), tissue bonding (scale: None, Some, Plenty), and tightness of sutures (scale: Loose, Somewhat tight, Tight) to measure durability.

  6 Months

Secondary Outcomes (10)

• %TBWL

  6 Month

• %EWL

  6 and 12 month

• Blood Pressure

  6 month

• HbA1c percentage

  6 Month

• Change in quality of life measured by Questionnaire: Short Form Health Survey (SF-36)

  6 Month

Study Arms (2)

Hybrid Argon Plasma Coagulation and Endoscopic Sleeve Gastroplasty

EXPERIMENTAL

Hybrid APC will be utilized to first ablate the gastric mucosa along the greater curve of the stomach, followed immediately by endoscopic full-thickness tissue acquisition and plication using 2-0 Prolene synthetic sutures via the Apollo ESG platform.

Procedure: Hybrid Argon Plasma Coagulation; Procedure: Endoscopic Sleeve Gastroplasty

Endoscopic Sleeve Gastroplasty

ACTIVE COMPARATOR

Endoscopic full-thickness tissue acquisition and plication using 2-0 Prolene synthetic sutures via the Apollo ESG platform.

Procedure: Endoscopic Sleeve Gastroplasty

Interventions

Hybrid Argon Plasma Coagulation PROCEDURE

Hybrid APC will be utilized to first ablate the gastric mucosa along the greater curve of the stomach.

Hybrid Argon Plasma Coagulation and Endoscopic Sleeve Gastroplasty

Endoscopic Sleeve Gastroplasty PROCEDURE

Endoscopic full-thickness tissue acquisition and plication using 2-0 Prolene synthetic sutures via the Apollo ESG platform.

Endoscopic Sleeve Gastroplasty; Hybrid Argon Plasma Coagulation and Endoscopic Sleeve Gastroplasty

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 21-65
• BMI ≥ 30 and ≤40 kg/m²
• Willingness to comply with the substantial lifelong dietary restrictions required by the procedure.
• History of failure with non-surgical weight-loss methods.
• Willingness to follow protocol requirements, including signed informed consent, routine follow-up schedule, completing laboratory tests, and completing diet counseling.
• Residing within a reasonable driving distance from the investigator's office (Cary, NC) and able to travel to the investigator to complete all routine follow-up visits as applicable
• Ability to give informed consent.
• Women of childbearing potential (i.e., not post-menopausal or surgically sterilized) must agree to use adequate birth control methods.
• Reliable access to wi-fi and/or internet services.

You may not qualify if:

• History of foregut or gastrointestinal (GI) surgery (except uncomplicated cholecystectomy or appendectomy).
• Prior gastrointestinal surgery with sequelae, i.e., obstruction, and/or adhesive peritonitis or known abdominal adhesions.
• Prior open or laparoscopic bariatric surgery.
• Prior surgery of any kind on the esophagus, stomach, or any type of hiatal hernia surgery.
• Any inflammatory disease of the gastrointestinal tract including severe (LA Grade C or D) esophagitis, Barrett's esophagus, gastric ulceration, duodenal ulceration, cancer, or specific inflammatory disease such as Crohn's disease or celiac 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.
• Gastrointestinal stromal tumors, history of premalignant gastric lesions (intestinal metaplasia), history of familial and nan-familial adenomatous syndromes.
• A gastric mass or gastric polyps \> 1 cm in size.
• A hiatal hernia \> 4cm of axial displacement of the z-line above the diaphragm or severe or intractable gastro-esophageal reflux symptoms.
• 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
• 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 a HgbA1C≥9.
• Subjects with any serious health condition unrelated to their weight that would increase the risk of endoscopy.
• Chronic abdominal pain.

Sponsors & Collaborators

• True You Weight Loss: lead
• Erbe USA Incorporated: collaborator
• Erbe Elektromedizin GmbH: collaborator

Study Sites (1)

True You Weight Loss

Cary, North Carolina, 27513, United States

Location

Related Publications (29)

• Hales CM, Carroll MD, Fryar CD, Ogden CL. Prevalence of Obesity and Severe Obesity Among Adults: United States, 2017-2018. NCHS Data Brief. 2020 Feb;(360):1-8.

  PMID: 32487284 BACKGROUND

• Ward ZJ, Bleich SN, Cradock AL, Barrett JL, Giles CM, Flax C, Long MW, Gortmaker SL. Projected U.S. State-Level Prevalence of Adult Obesity and Severe Obesity. N Engl J Med. 2019 Dec 19;381(25):2440-2450. doi: 10.1056/NEJMsa1909301.

  PMID: 31851800 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

• Wadden TA, Butryn ML, Wilson C. Lifestyle modification for the management of obesity. Gastroenterology. 2007 May;132(6):2226-38. doi: 10.1053/j.gastro.2007.03.051.

  PMID: 17498514 BACKGROUND

• Kheniser K, Saxon DR, Kashyap SR. Long-Term Weight Loss Strategies for Obesity. J Clin Endocrinol Metab. 2021 Jun 16;106(7):1854-1866. doi: 10.1210/clinem/dgab091.

  PMID: 33595666 BACKGROUND

• Wilding JPH, Batterham RL, Calanna S, Davies M, Van Gaal LF, Lingvay I, McGowan BM, Rosenstock J, Tran MTD, Wadden TA, Wharton S, Yokote K, Zeuthen N, Kushner RF; STEP 1 Study Group. Once-Weekly Semaglutide in Adults with Overweight or Obesity. N Engl J Med. 2021 Mar 18;384(11):989-1002. doi: 10.1056/NEJMoa2032183. Epub 2021 Feb 10.

  PMID: 33567185 BACKGROUND

• Wadden TA, Bailey TS, Billings LK, Davies M, Frias JP, Koroleva A, Lingvay I, O'Neil PM, Rubino DM, Skovgaard D, Wallenstein SOR, Garvey WT; STEP 3 Investigators. Effect of Subcutaneous Semaglutide vs Placebo as an Adjunct to Intensive Behavioral Therapy on Body Weight in Adults With Overweight or Obesity: The STEP 3 Randomized Clinical Trial. JAMA. 2021 Apr 13;325(14):1403-1413. doi: 10.1001/jama.2021.1831.

  PMID: 33625476 BACKGROUND

• Davies M, Faerch L, Jeppesen OK, Pakseresht A, Pedersen SD, Perreault L, Rosenstock J, Shimomura I, Viljoen A, Wadden TA, Lingvay I; STEP 2 Study Group. Semaglutide 2.4 mg once a week in adults with overweight or obesity, and type 2 diabetes (STEP 2): a randomised, double-blind, double-dummy, placebo-controlled, phase 3 trial. Lancet. 2021 Mar 13;397(10278):971-984. doi: 10.1016/S0140-6736(21)00213-0. Epub 2021 Mar 2.

  PMID: 33667417 BACKGROUND

• Enebo LB, Berthelsen KK, Kankam M, Lund MT, Rubino DM, Satylganova A, Lau DCW. Safety, tolerability, pharmacokinetics, and pharmacodynamics of concomitant administration of multiple doses of cagrilintide with semaglutide 2.4 mg for weight management: a randomised, controlled, phase 1b trial. Lancet. 2021 May 8;397(10286):1736-1748. doi: 10.1016/S0140-6736(21)00845-X. Epub 2021 Apr 22.

  PMID: 33894838 BACKGROUND

• Bal BS, Finelli FC, Shope TR, Koch TR. Nutritional deficiencies after bariatric surgery. Nat Rev Endocrinol. 2012 Sep;8(9):544-56. doi: 10.1038/nrendo.2012.48. Epub 2012 Apr 24.

  PMID: 22525731 BACKGROUND

• Proietto J. Why is treating obesity so difficult? Justification for the role of bariatric surgery. Med J Aust. 2011 Aug 1;195(3):144-6. doi: 10.5694/j.1326-5377.2011.tb03242.x.

  PMID: 21806533 BACKGROUND

• Hedjoudje A, Abu Dayyeh BK, Cheskin LJ, Adam A, Neto MG, Badurdeen D, Morales JG, Sartoretto A, Nava GL, Vargas E, Sui Z, Fayad L, Farha J, Khashab MA, Kalloo AN, Alqahtani AR, Thompson CC, Kumbhari V. Efficacy and Safety of Endoscopic Sleeve Gastroplasty: A Systematic Review and Meta-Analysis. Clin Gastroenterol Hepatol. 2020 May;18(5):1043-1053.e4. doi: 10.1016/j.cgh.2019.08.022. Epub 2019 Aug 20.

  PMID: 31442601 BACKGROUND

• Sharaiha RZ, Hajifathalian K, Kumar R, Saunders K, Mehta A, Ang B, Skaf D, Shah S, Herr A, Igel L, Dawod Q, Dawod E, Sampath K, Carr-Locke D, Brown R, Cohen D, Dannenberg AJ, Mahadev S, Shukla A, Aronne LJ. Five-Year Outcomes of Endoscopic Sleeve Gastroplasty for the Treatment of Obesity. Clin Gastroenterol Hepatol. 2021 May;19(5):1051-1057.e2. doi: 10.1016/j.cgh.2020.09.055. Epub 2020 Oct 1.

  PMID: 33011292 BACKGROUND

• Mahmoud T, Vargas EJ, Ghazi R, Abusaleh R, Storm AC, Abu Dayyeh BK. The Osculating Circles Gastroplasty: A Novel Endoscopic Submucosal Resection Enhanced Endoluminal Suturing for Obesity. Gastroenterology. 2021 Dec;161(6):1806-1808.e1. doi: 10.1053/j.gastro.2021.08.059. Epub 2021 Sep 26. No abstract available.

  PMID: 34587488 BACKGROUND

• Zenker M. Argon plasma coagulation. GMS Krankenhhyg Interdiszip. 2008 Nov 3;3(1):Doc15.

  PMID: 20204117 BACKGROUND

• Jirapinyo P, de Moura DTH, Dong WY, Farias G, Thompson CC. Dose response for argon plasma coagulation in the treatment of weight regain after Roux-en-Y gastric bypass. Gastrointest Endosc. 2020 May;91(5):1078-1084. doi: 10.1016/j.gie.2019.12.036. Epub 2020 Jan 3.

  PMID: 31904378 BACKGROUND

• Itani MI, Farha J, Sartoretto A, Abbarh S, Badurdeen D, de Moura DTH, Kumbhari V. Endoscopic sleeve gastroplasty with argon plasma coagulation: A novel technique. J Dig Dis. 2020 Nov;21(11):664-667. doi: 10.1111/1751-2980.12939.

  PMID: 32916766 BACKGROUND

• Lee JH, Johannes RS, Van Dam J, et al. 7087 Argon plasma coagulation in endoscopic therapy. Gastrointestinal Endoscopy 2000;51:AB264.

  BACKGROUND

• Mitchell NS, Catenacci VA, Wyatt HR, Hill JO. Obesity: overview of an epidemic. Psychiatr Clin North Am. 2011 Dec;34(4):717-32. doi: 10.1016/j.psc.2011.08.005.

  PMID: 22098799 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

• Marchesini SD, Baretta GA, Cambi MP, Marchesini JB. Endoscopic plasma argon coagulation in treatment of weight regain after bariatric surgery: what does the patient think about this? Arq Bras Cir Dig. 2014;27 Suppl 1(Suppl 1):47-50. doi: 10.1590/s0102-6720201400s100012.

  PMID: 25409966 BACKGROUND

• Dhindsa BS, Saghir SM, Naga Y, Dhaliwal A, Ramai D, Cross C, Singh S, Bhat I, Adler DG. Efficacy of transoral outlet reduction in Roux-en-Y gastric bypass patients to promote weight loss: a systematic review and meta-analysis. Endosc Int Open. 2020 Oct;8(10):E1332-E1340. doi: 10.1055/a-1214-5822. Epub 2020 Sep 22.

  PMID: 33015335 BACKGROUND

• Storm AC, Thompson CC. Endoscopic Treatments Following Bariatric Surgery. Gastrointest Endosc Clin N Am. 2017 Apr;27(2):233-244. doi: 10.1016/j.giec.2016.12.007.

  PMID: 28292402 BACKGROUND

• Jaruvongvanich V, Vantanasiri K, Laoveeravat P, Matar RH, Vargas EJ, Maselli DB, Alkhatry M, Fayad L, Kumbhari V, Fittipaldi-Fernandez RJ, Hollenbach M, Watson RR, Gustavo de Quadros L, Galvao Neto M, Aepli P, Staudenmann D, Brunaldi VO, Storm AC, Martin JA, Gomez V, Abu Dayyeh BK. Endoscopic full-thickness suturing plus argon plasma mucosal coagulation versus argon plasma mucosal coagulation alone for weight regain after gastric bypass: a systematic review and meta-analysis. Gastrointest Endosc. 2020 Dec;92(6):1164-1175.e6. doi: 10.1016/j.gie.2020.07.013. Epub 2020 Jul 18.

  PMID: 32692991 BACKGROUND

• Catalano MF, Rudic G, Anderson AJ, Chua TY. Weight gain after bariatric surgery as a result of a large gastric stoma: endotherapy with sodium morrhuate may prevent the need for surgical revision. Gastrointest Endosc. 2007 Aug;66(2):240-5. doi: 10.1016/j.gie.2006.06.061. Epub 2007 Feb 28.

  PMID: 17331511 BACKGROUND

• Baretta GA, Alhinho HC, Matias JE, Marchesini JB, de Lima JH, Empinotti C, Campos JM. Argon plasma coagulation of gastrojejunal anastomosis for weight regain after gastric bypass. Obes Surg. 2015 Jan;25(1):72-9. doi: 10.1007/s11695-014-1363-2.

  PMID: 25005812 BACKGROUND

• de Moura DTH, Badurdeen DS, Ribeiro IB, Leite EFMDSD, Thompson CC, Kumbhari V. Perspectives toward minimizing the adverse events of endoscopic sleeve gastroplasty. Gastrointest Endosc. 2020 Nov;92(5):1115-1121. doi: 10.1016/j.gie.2020.06.038. Epub 2020 Jun 17. No abstract available.

  PMID: 32562607 BACKGROUND

Related Links

• Sponsor Site

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Christopher E McGowan, MD, MSCR

  CEO/Medical Director

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Participants and care providers will be blinded to the results of randomization. They will remain blinded until the end of the study, or if there is a medical or surgical safety concern.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 1:1 allocation to experimental and control group using variable block randomization

Study Record Dates

• First Submitted: April 24, 2023
• First Posted: May 23, 2023
• Study Start: May 18, 2023
• Primary Completion: March 1, 2025
• Study Completion: May 1, 2025
• Last Updated: April 8, 2024

Record last verified: 2024-04

Locations

US (1)