Efficacy and Safety of Endoscopic Antral Myotomy as a Novel Weight Loss Procedure

NCT05711758 | Recruiting

• 1 other identifier: 2022P003420
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Gastric myotomy has been performed for several years as a means of addressing chronic stenosis after sleeve gastrectomy and treating gastroparesis. The Pylorus Sparing Antral Myotomy (PSAM) technique has the opposite effect by leaving the pylorus intact and extending the myotomy proximally to the distal gastric body. PSAM was initially combined with ESG and shown to delay gastric emptying and provide greater weight loss without impacting tolerability (GCSI score) or the safety profile of the procedure (2 DDW GEM abstracts). PSAM has not been evaluated alone, without concomitant ESG. Since delayed gastric emptying alone is known to promote weight loss, it is thought that PSAM alone (without ESG) may provide similar efficacy, while reducing procedure time and adverse events. There have been no clinical studies that investigate the efficacy of PSAM independent of ESG. This pilot study aims to address this lack of information by evaluating the safety, tolerability, and short-term efficacy of PSAM, in addition to exploring its impact on gastric physiology. This will also provide data that may be used in designing a larger clinical trial.

Conditions

Obesity; Obesity, Morbid; Obesity, Primary; Metabolic Disease; Delayed Gastric Emptying Following Procedure

Keywords

Pylorus Sparing Antral Myotomy (PSAM); Gastric physiology; Gastric emptying; Pylorus-sparing antral myotomy; Myotomy; Endoscopic Sleeve Gastroplasty (ESG); TransPyloric Shuttle (TPS); Intragastric balloon (IGB); Endoscopic bariatric and metabolic therapies (EBMT); Gut Hormones; Gastric Emptying Breath Test

Outcome Measures

Primary Outcomes (3)

• Weight change compared to baseline

  Percent total body weight loss

  Screening, Procedure day, 1 month, 3 month, 6 month, 9 month, 12 months

• Adverse Events

  Changes to health compared to baseline

  Procedure day, 1 month, 3 month, 6 month, 9 month, 12 months

• Change in tolerability from procedure day to 12 months

  How the subjects feel after the procedure based on pain scale and AE's

  Procedure day, 1 month, 3 month, 6 month, 9 month, 12 months

Secondary Outcomes (9)

• Change in Quality of Life compared to baseline

  Screening, 1 month, 3 month, 6 month, 9 month, 12 months

• Gastric Emptying compared to baseline

  Screening, 6 months, 12 months

• Ghrelin levels compared to baseline

  Screening, 6 months, 12 months

• Insulin levels compared to baseline

  Screening, 6 months, 12 months

• HgA1c levels compared to baseline

  Screening, 6 months, 12 months

Study Arms (3)

PSAM Treatment Patients with no prior endoscopic bariatric therapies

Subjects with no prior endoscopic bariatric therapies having esophagogastroduodenoscopy (EGD) with Pylorus Sparing Antral Myotomy (PSAM) with standard of care lifestyle modification therapy.

Procedure: PSAM Treatment Patients

PSAM Treatment Patients with prior primary endoscopic bariatric therapies

Subjects with prior primary endoscopic bariatric therapies having esophagogastroduodenoscopy (EGD) with Pylorus Sparing Antral Myotomy (PSAM) with standard of care lifestyle modification therapy.

Procedure: PSAM Treatment Patients

PSAM Treatment Patients with prior revision endoscopic bariatric therapies

Subjects with prior revision endoscopic bariatric therapies having esophagogastroduodenoscopy (EGD) with Pylorus Sparing Antral Myotomy (PSAM) with standard of care lifestyle modification therapy.

Procedure: PSAM Treatment Patients

Interventions

PSAM Treatment Patients PROCEDURE

PSAM is a pylorus-sparing antral myotomy performed under general anesthesia. Endoscopic myotomy is then performed applying the principles of submucosal endoscopy and techniques used during gastric per-oral endoscopic myotomy (G-POEM). A submucosal bleb is created proximal to the pylorus. A longitudinal mucosal incision is made with an endoscopic knife. The endoscope is then introduced into the submucosal space, and the knife is used to dissect the submucosal fibers. Antral myotomy is performed starting proximal to the pyloric ring extending to the mucosal access site. The myotomy entails cutting of the inner circular and oblique muscle bundles or may be full thickness at the discretion of the endoscopist. The mucosal entry is then closed using endoscopic suturing or clips.

Also known as: PSAM

PSAM Treatment Patients with no prior endoscopic bariatric therapies; PSAM Treatment Patients with prior primary endoscopic bariatric therapies; PSAM Treatment Patients with prior revision endoscopic bariatric therapies

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults in the Center for Weight Management and Wellness program at Brigham and Women's Hospital with a BMI \>35 kg/m2 who are pre-qualified by their insurance as recommended by their specialist to undergo an endoscopic bariatric procedure.

You may qualify if:

• subjects must be 18-70 years of age
• eligible for endoscopic and surgical weight loss procedures
• body mass index (BMI) greater than 35 kg/m2
• Individuals must be in excellent mental health
• able to understand and sign informed consent
• available to return for all routine follow-up study visits

You may not qualify if:

• untreated H. pylori infection
• gastroparesis
• active smoking
• an ongoing or a history of treatment with opioids in the last 12 months prior to enrollment
• previous pyloromyotomy or pyloroplasty
• gastrointestinal obstruction
• severe coagulopathy
• esophageal or gastric varices and/or portal hypertensive gastropathy
• pregnancy or puerperium
• any inflammatory disease of the gastrointestinal tract (including but not limited to severe (LA Grade C or D) esophagitis, active gastric ulceration, active duodenal ulceration, or specific inflammation such as Crohn's disease)
• malignant or premalignant gastric diseases (such as high grade dysplasia, gastric cancer, or GIST)
• severe cardiopulmonary disease or a history of coronary artery disease (including myocardial infarction within the past 6 months, poorly controlled hypertension, required use of NSAIDs)
• lactation
• history of gastrointestinal surgery
• any serious health condition unrelated to their weight that would increase the risk of endoscopy

Sponsors & Collaborators

• Christopher C. Thompson, MD, MSc: lead

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

RECRUITING

Related Publications (10)

• Klem ML, Wing RR, Chang CC, Lang W, McGuire MT, Sugerman HJ, Hutchison SL, Makovich AL, Hill JO. A case-control study of successful maintenance of a substantial weight loss: individuals who lost weight through surgery versus those who lost weight through non-surgical means. Int J Obes Relat Metab Disord. 2000 May;24(5):573-9. doi: 10.1038/sj.ijo.0801199.

  PMID: 10849578 BACKGROUND

• James PT, Leach R, Kalamara E, Shayeghi M. The worldwide obesity epidemic. Obes Res. 2001 Nov;9 Suppl 4:228S-233S. doi: 10.1038/oby.2001.123.

  PMID: 11707546 BACKGROUND

• Jia H, Lubetkin EI. Obesity-related quality-adjusted life years lost in the U.S. from 1993 to 2008. Am J Prev Med. 2010 Sep;39(3):220-7. doi: 10.1016/j.amepre.2010.03.026.

  PMID: 20709253 BACKGROUND

• Tak YJ, Lee SY. Anti-Obesity Drugs: Long-Term Efficacy and Safety: An Updated Review. World J Mens Health. 2021 Apr;39(2):208-221. doi: 10.5534/wjmh.200010. Epub 2020 Mar 9.

  PMID: 32202085 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

• Gomez V, Woodman G, Abu Dayyeh BK. Delayed gastric emptying as a proposed mechanism of action during intragastric balloon therapy: Results of a prospective study. Obesity (Silver Spring). 2016 Sep;24(9):1849-53. doi: 10.1002/oby.21555. Epub 2016 Jul 28.

  PMID: 27465076 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

• Goyal RK, Guo Y, Mashimo H. Advances in the physiology of gastric emptying. Neurogastroenterol Motil. 2019 Apr;31(4):e13546. doi: 10.1111/nmo.13546. Epub 2019 Feb 10.

  PMID: 30740834 BACKGROUND

• Aghaie Meybodi M, Qumseya BJ, Shakoor D, Lobner K, Vosoughi K, Ichkhanian Y, Khashab MA. Efficacy and feasibility of G-POEM in management of patients with refractory gastroparesis: a systematic review and meta-analysis. Endosc Int Open. 2019 Mar;7(3):E322-E329. doi: 10.1055/a-0812-1458. Epub 2019 Feb 28.

  PMID: 30842971 BACKGROUND

• Mohan BP, Chandan S, Jha LK, Khan SR, Kotagiri R, Kassab LL, Ravikumar NPG, Bhogal N, Chandan OC, Bhat I, Hewlett AT, Jacques J, Ponnada S, Asokkumar R, Adler DG. Clinical efficacy of gastric per-oral endoscopic myotomy (G-POEM) in the treatment of refractory gastroparesis and predictors of outcomes: a systematic review and meta-analysis using surgical pyloroplasty as a comparator group. Surg Endosc. 2020 Aug;34(8):3352-3367. doi: 10.1007/s00464-019-07135-9. Epub 2019 Oct 3.

  PMID: 31583465 BACKGROUND

Related Links

• Safety information for TransPyloric Shuttle/TransPyloric Shuttle Delivery Device

MeSH Terms

Conditions

Obesity; Obesity, Morbid; Metabolic Diseases

Condition Hierarchy (Ancestors)

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

Study Officials

• Christopher C. Thompson, MD, MSc

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michele B. Ryan, MS

CONTACT

6176765928; mryan@bwh.harvard.edu

Study Design

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

Study Record Dates

• First Submitted: December 29, 2022
• First Posted: February 3, 2023
• Study Start: September 22, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: March 2, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)