Recruiting

Endoscopic Sleeve Gastroplasty

Sponsor:

The Methodist Hospital Research Institute

Code:

NCT06339320

Conditions

Endoscopic Sleeve Gastroplasty

Obesity

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Endoscopic Sleeve Gastroplasty (ESG)

Apollo OverStitch endoscopic suturing device

Study Details

Brief summary:

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).

Conditions

Endoscopic Sleeve Gastroplasty

Obesity

Study ID

NCT06339320

Start date

Feb 28, 2024

Status verified date

Mar, 2024

Completion date

Oct, 2033

Anticipated

Primary completion date

Oct, 2033

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

150 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

other: ESG Procedure

Endoscopic Sleeve Gastroplasty for patients with obesity using the Apollo OverStitch endoscopic suturing device.

Interventions

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.

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.

Primary outcome measure

  • Number of participants with technically successful completion of the ESG procedure [ Time Frame: 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 ]

Central Contacts and Locations

Central contacts

Thomas R McCarty, MD, MPH

713-363-7436tommccarty3@houstonmethodist.org

Locations

Houston Methodist Hospital

Recruiting

Houston, Texas, United States, 77030

Contacts

Thomas R McCarty, MD, MPH

713-363-7436tommccarty3@houstonmethodist.org

Houston Methodist Hospital - Sugarland

Recruiting

Sugar Land, Texas, United States, 77479

Contacts

Thomas R McCarty, MD, MPH

713-363-7436tommccarty3@houstonmethodist.org

More Information

Sponsor

The Methodist Hospital Research Institute

Last update posted

Apr 1, 2024

Last verified

Mar, 2024

Keywords

  • Obesity
  • Weight loss
  • Endoscopic Sleeve Gastroplasty (ESG)

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by The Methodist Hospital Research Institute on 2024-04-01.