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

December 13, 2023 updated by: Christopher C. Thompson, MD, MSc

Efficacy and Safety of Endoscopic Antral Myotomy as a Novel Weight Loss Procedure: A Pilot Study

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Obesity, defined as body mass index (BMI) greater than 30 kg/m2 in adults, is affecting 30% of the global population and a significant healthcare burden. [1] Obesity has increased dramatically over the last few decades, with over 650 million adults, or 13% of the world's total adult population, diagnosed with the disease in 2016 - a figure that has nearly tripled since 1975.[1] In the U.S the obesity prevalence for U.S. adults increased from 14.1% to 26.7%, or an 89.9% increase between 1993 and 2008.[1,2,3] As a result, current and potential interventions, and treatment strategies to combat obesity have become more important.

The current treatment of obesity involves multiple strategies with combination of non-pharmacologic, pharmacologic, endoscopic, and surgical interventions. There are several FDA-approved pharmacotherapies for the treatment of obesity such as orlistat, phentermine-topiramate, naltrexone-bupropion, liraglutide, and semaglutide. For adults with a body mass index (BMI) of 40 kg/m2 or 35 kg/m2 and obesity-related comorbidity, bariatric surgery can be offered. [4, 5] Endoscopic bariatric and metabolic therapies (EBMT) have emerged as an alternative treatment for patients with obesity with a BMI over 30kg/m2 or 27 kg/m2 with an obesity-related comorbidity. The interest in EBMT is growing given their safety, efficacy, and non-invasive nature. Current FDA-cleared devices that can be used for EBMT include intragastric balloons and suturing devices for endoscopic sleeve gastroplasty (ESG). Additionally, a variety of Endo surgical knifes are approved for tissue dissection such as myotomy.

Gastric interventions used to treat obesity work by interfering with gastric accommodation, breakdown and mixing of food, or gastric emptying. Delaying gastric emptying was shown to be a major mechanism of action for both ESG and IGB which is also correlated with weight loss [6].

Antral peristalsis constitutes an important mechanism for gastric emptying. The antrum also serves as a food sensor which needs to be filled to a certain level before food is pumped into the duodenum. [7] Therefore, targeting the antrum is a feasible strategy to delay gastric emptying, induce satiety, and promote weight loss.

In fact, one of the recently FDA-cleared EBMT devices, the Transpyloric Shuttle (Baronova, MA), focuses on inhibiting the antral pump as its primary mechanism of action. This device consists of two interconnected large and small bulbs, positioned in the antrum and duodenum respectively, that cause intermittent obstruction of the pylorus, leading to a delay in gastric emptying (10).

As such, a pylorus sparing antral myotomy (PSAM) with a submucosal tunneling technique was developed. Gastric myotomy has been performed for several years as a means of addressing chronic stenosis after sleeve gastrectomy and treating gastroparesis. The 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.

Traditional bariatric surgery is very effective at treating obesity, however, only 1% of eligible patients elect to undergo this treatment option. Additionally, the majority of patients with obesity do not qualify for bariatric surgery. [5] Due to the less invasive nature of PSAM, and relative technical simplicity compared to ESG) this procedure may provide a more widely available and more acceptable treatment option for some patients.

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.

Study Type

Observational

Enrollment (Estimated)

6

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Recruiting
        • Brigham and Women's Hospital
        • Principal Investigator:
          • Christopher C. Thompson, MD, MSc
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

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.

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • chronic abdominal pain
  • active psychological issues preventing participation in a lifestyle modification program
  • a known history of endocrine disorders affecting weight (uncontrolled hypothyroidism)
  • an inability to provide informed consent
  • use of any medication that may interfere with weight loss
  • use of any medication that may interfere with gastric emptying
  • any other condition which the investigator may deem as an impediment to compliance or hinder completion of the proposed study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
PSAM Treatment Patients
Subjects having esophagogastroduodenoscopy (EGD) with Pylorus Sparing Antral Myotomy (PSAM) with standard of care lifestyle modification therapy.
Procedure: PSAM Treatment Patients
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.
Other Names:
  • PSAM

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Weight change compared to baseline
Time Frame: Screening, Procedure day, 1 month, 3 month, 6 month, 9 month, 12 months
Percent total body weight loss
Screening, Procedure day, 1 month, 3 month, 6 month, 9 month, 12 months
Adverse Events
Time Frame: Procedure day, 1 month, 3 month, 6 month, 9 month, 12 months
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
Time Frame: Procedure day, 1 month, 3 month, 6 month, 9 month, 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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gastric Emptying compared to baseline
Time Frame: Screening, 6 months, 12 months
Gastric emptying using a gastric emptying breath test (GEBT)
Screening, 6 months, 12 months
Ghrelin levels compared to baseline
Time Frame: Screening, 6 months, 12 months
Laboratory analysis of blood samples to test ghrelin levels
Screening, 6 months, 12 months
Change in Quality of Life compared to baseline
Time Frame: Screening, 1 month, 3 month, 6 month, 9 month, 12 months
Overall quality of life questionnaire
Screening, 1 month, 3 month, 6 month, 9 month, 12 months
Insulin levels compared to baseline
Time Frame: Screening, 6 months, 12 months
Laboratory analysis of blood samples to test insulin metabolic profiles
Screening, 6 months, 12 months
HgA1c levels compared to baseline
Time Frame: Screening, 6 months, 12 months
Laboratory analysis of blood samples to test HgA1c metabolic profiles
Screening, 6 months, 12 months
Glucose levels compared to baseline
Time Frame: Screening, 6 months, 12 months
Laboratory analysis of blood samples to test Glucose metabolic profiles
Screening, 6 months, 12 months
HOMA-IR blood plasma levels compared to baseline
Time Frame: Screening, 6 months, 12 months
Laboratory analysis of blood samples to test changes in insulin resistance
Screening, 6 months, 12 months
Physiologic Changes of gastric motility/transit compared to baseline
Time Frame: Screening, 6 months, 12 months
Upper GI series comparing pre-procedure barium transit to post-procedure 6 and 12 month time points.
Screening, 6 months, 12 months
Gastric Motility compared to baseline
Time Frame: Screening, 1 month
Dynamic MRI
Screening, 1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Christopher C. Thompson, MD, MSc

Investigators

  • Principal Investigator: Christopher C. Thompson, MD, MSc, Brigham and Women's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 22, 2023

Primary Completion (Estimated)

September 21, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

December 29, 2022

First Submitted That Met QC Criteria

January 25, 2023

First Posted (Actual)

February 3, 2023

Study Record Updates

Last Update Posted (Actual)

December 19, 2023

Last Update Submitted That Met QC Criteria

December 13, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022P003420

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

As this is a pilot study to collect data for a larger NIH grant submission, we do not have plans to share data at this time.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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