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Endoscopic Sleeve Gastroplasty (ESG) for Obesity

This study is looking at Endoscopic Sleeve Gastroplasty (ESG) for treating obesity. ESG is a procedure that uses a special device called the Apollo OverStitch endoscopic suturing device to help people lose weight. This device is approved by the FDA for adults with obesity (BMI 30-50 kg/m2) who haven't been able to lose weight or keep it off with diet and exercise alone. The study wants to see how many people successfully complete the ESG procedure and if there are any side effects within 30 days after the procedure. We don't know the current enrollment status.

Study design
This is an interventional study planning to enroll 150 participants. It is not specified if it is randomized or blinded.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 30 days after the procedure to check for any side effects.

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NCT06339320

Endoscopic Sleeve Gastroplasty (ESG) for the Treatment of Obesity

Recruiting
NAAges 18+InterventionalTreatment
The Methodist Hospital Research Institute
~150 participants
Updated 2024-04-01 on ClinicalTrials.gov
What's tested:Endoscopic Sleeve Gastroplasty (ESG)Apollo OverStitch endoscopic suturing device

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of participants with technically successful completion of the ESG procedure
Measured over Procedural completion over 10 year period
+1 more outcome measured

Conditions

Endoscopic Sleeve Gastroplasty
Obesity

Explore related trials

Obesity

Where it's being run

2 sites across 1 states
Texas2

Study leadership

  • Thomas R McCarty, MD, MPH · PRINCIPAL_INVESTIGATOR · The Methodist Hospital Research Institute

Who to contact

Thomas R McCarty, MD, MPH
[email protected]
713-363-7436
Email the study team

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Number of participants with technically successful completion of the ESG procedureProcedural 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.

  • Number of participants with treatment-related adverse events as assessed by CTCAE v4.030 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.