Endoscopic Sleeve Gastroplasty (ESG) for the Treatment of Obesity

March 24, 2024 updated by: Thomas R McCarty, MD, MPH, The Methodist Hospital Research Institute
The purpose of this study is to evaluate endoscopic sleeve gastroplasty (ESG) for the treatment of obesity. The ESG procedure is an U.S. Food and Drug Administration (FDA) approved procedure for the treatment of obesity - patients with a body mass index (BMI) 30-50 kg/m2. This procedure is FDA approved; however, Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program (MBSAQIP)-Accredited centers (such as Houston Methodist Hospital) must receive approval from an Institutional Review Board (IRB) in order to perform primary procedures, such as ESG, that are not endorsed by the American Society for Metabolic and Bariatric Surgery (ASMBS).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Obesity has become an epidemic on a national and international scale with immense burden of disease. Approximately one out of every three United States (U.S.) adults are characterized as having obesity with the global prevalence having nearly tripled over the last four decades to include over 650 million people. Although diet and exercise are essential, these interventions alone typically result in only 1-3% total weight loss. Pharmacotherapy is effective but has side effects and carries the risk of weight recurrence once discontinued. While bariatric surgery is the most robust treatment option, only 1% of eligible patients undergo surgery, leaving a tremendous need for effective and safe therapies.

Helping to bridge this gap in available treatments, the endoscopic sleeve gastroplasty (ESG) procedure provides a way to improve access to validated, efficacious, and safe anti-obesity treatments. ESG is an endoscopic weight loss procedure. The procedure uses an endoscopic suturing device, which has received FDA authorization as a minimally invasive procedure to facilitate weight loss for adults with obesity (BMI 30-50 kg/m2) who have been unable to lose weight or maintain weight loss through more conservative measures such as diet and exercise. This procedure involves endoscopic suturing to reduce the volume of the stomach endoscopically by approximately 70% to 80% its original size. Following the procedure, the new stomach appears similar to the surgical sleeve stomach, although the procedure is considered less invasive with fewer complications compared to a surgical sleeve procedure.

This study aims to perform ESG for patients with obesity, defined as a BMI 30-50 kg/m2. Additionally, data collection of relevant weight-related and metabolic outcomes, including comorbidity resolution will be collected retrospectively from the study to assess efficacy and safety of the ESG procedure. Data collection for the MBSAQIP registry will be recorded on a monthly basis.

Study Type

Interventional

Enrollment (Estimated)

150

Phase

  • Not Applicable

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
    • Texas
      • Houston, Texas, United States, 77030
      • Sugar Land, Texas, United States, 77479

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients with BMI 30 to 50 kg/m2
  • Patients that have been unable able to lose weight, or maintain weight loss, through more conservative measures (i.e., lifestyle interventions including diet and exercise) per the FDA approval for the Apollo ESG device. Lifestyle interventions may include traditional diet and anaerobic or aerobic exercise, including resistance training.

Exclusion Criteria:

  • Patients who are actively pregnant
  • Active tobacco use (defined as tobacco within 4 weeks prior to the procedure)
  • Active gastric mucosal lesions
  • Active bleeding or potential bleeding gastric lesions (i.e., ulcers, erosive gastritis, varices, or vascular malformations)
  • Neoplastic lesions (i.e., esophageal, gastric, or small bowel cancer)
  • Hiatal hernia >5 cm
  • Severe coagulopathy and antiplatelet/anticoagulant therapy that cannot be corrected
  • Psychiatric disorders not assessed or cleared by a psychologist or psychiatrist actively participating in that patient's care (i.e., affective disorders not under medical supervision or refractory to medical therapy and all eating disorders such as anorexia nervosa, binge eating disorder, specified feeding and eating disorders, avoidant restrictive food intake, and rumination)
  • Patients with endoscopic interventions that are contraindicated

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

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: ESG Procedure
Endoscopic Sleeve Gastroplasty for patients with obesity using the Apollo OverStitch endoscopic suturing device.
Procedure: Endoscopic Sleeve Gastroplasty (ESG)
The ESG procedure uses the Apollo OverStitch endoscopic suturing device, which has received FDA authorization as a minimally invasive procedure to facilitate weight loss for adults with who have been unable to lose weight or maintain weight loss through more conservative measures such as diet and exercise. This procedure involves endoscopic suturing to reduce the volume of the stomach endoscopically by approximately 70% to 80% its original size. Using the Apollo OverStitch or APOLLO ESG and ESG SX Systems, the ESG procedure is performed be folding the stomach in on itself (endoscopically) and placing full-thickness sutures through the wall of the stomach to maintain this narrow, smaller size. Following the procedure, the new stomach appears similar to the surgical sleeve stomach, although the procedure is considered less invasive with fewer complications compared to a surgical sleeve gastrectomy.
Device: Apollo OverStitch endoscopic suturing device
Apollo ESG is the first and only device to be authorized by the FDA to perform the ESG procedure to facilitate weight loss in patients with obesity (BMI 30 to 50 kg/m2). The FDA identifies this generic type of device as an Endoscopic suturing device for altering gastric anatomy for weight loss.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with technically successful completion of the ESG procedure
Time Frame: Procedural completion over 10 year period
Per the ASMBS, IRB approval must be for performing the ESG procedure, and not solely for data collection of outcomes from these procedures, with data collected by the MBSAQIP registry. Therefore, the primary outcome is performing the ESG procedure (defined as ability to successful complete the procedure). Procedural success will be defined by ability to successful reduce the size of the stomach using the Apollo OverStitch or APOLLO ESG and ESG SX systems. Technical success further identified by ability to insert the endoscopic suturing device, perform endoscopic reduction of the stomach, and success removal of the device.
Procedural completion over 10 year period
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time Frame: 30 days post-procedure
Treatment-related adverse events as assessed by CTCAE v4.0 will be reviewed on a monthly basis by the bariatric medical director, bariatric clinical review, and program manager. Per the U.S. FDA, identified risks to health including device- and/or procedure-related adverse events include: death, gastrointestinal bleeding, obstruction, perforation, injury to organs adjacent to the stomach, perigastric leak, and nausea, infection, pain, pneumoperitoneum, pneumothorax, and pulmonary embolism, weight gain, and adverse tissue reaction. All patients are recorded and entered into this MBSAQIP registry with outcomes tracked in real-time via the electronic medical record, and all ESG complications discussed at the Metabolic and Bariatric Surgery Committee Meetings which are held quarterly. This includes monitoring emergency department visits, readmissions, and patient transfers to any inpatient facility during the 30-day postoperative period.
30 days post-procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in body mass index (BMI) measured by kg/m2
Time Frame: BMI (kg/m2) measured day of procedure, 4 weeks, 3 months, 6 months, and 12 month intervals
Data collection of relevant weight-related outcomes, including body mass index (BMI, measured in kg/m2) will be performed on day of procedure and at relevant follow-up periods (day of procedure, 4 weeks, 3 months, 6 months, and 12 month intervals). From this, change in BMI with be measured to determine change at relevant follow-up intervals.
BMI (kg/m2) measured day of procedure, 4 weeks, 3 months, 6 months, and 12 month intervals
Change in hemoglobin A1C (%)
Time Frame: A1C measured pre-procedure, 3 months, 6 months, and 12 month intervals
Data collection of relevant comorbidity-related outcomes, including A1C (measured in percentage) will be performed pre-procedure and at relevant follow-up periods (pre-procedure, 3 months, 6 months, and 12 month intervals). This will be measured for all patients, regardless of presence or absence of diabetes mellitus (DM). From this, change in A1C will be calculated to determine and change in blood glucose (A1C).
A1C measured pre-procedure, 3 months, 6 months, and 12 month intervals

Collaborators and Investigators

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

Sponsor

The Methodist Hospital Research Institute

Investigators

  • Principal Investigator: Thomas R McCarty, MD, MPH, The Methodist Hospital Research Institute

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

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)

February 28, 2024

Primary Completion (Estimated)

October 1, 2033

Study Completion (Estimated)

October 1, 2033

Study Registration Dates

First Submitted

March 11, 2024

First Submitted That Met QC Criteria

March 24, 2024

First Posted (Actual)

April 1, 2024

Study Record Updates

Last Update Posted (Actual)

April 1, 2024

Last Update Submitted That Met QC Criteria

March 24, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRO00037835

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

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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