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ESG Procedure for Obesity

N/A

Recruiting

Led By Thomas R McCarty, MD, MPH

Research Sponsored by The Methodist Hospital Research Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up procedural completion over 10 year period

Awards & highlights

Study Summary

This trial aims to study the effectiveness of endoscopic sleeve gastroplasty (ESG) in treating obesity. ESG is an approved procedure by the FDA for patients with a BMI of 30-

Who is the study for?

This trial is for individuals with obesity, having a BMI between 30 to 50 kg/m2, who haven't successfully lost weight through diet and exercise. It's not suitable for those with large hiatal hernias, severe blood clotting issues, recent tobacco use, active pregnancy, bleeding stomach lesions or cancers of the digestive tract.Check my eligibility

What is being tested?

The study tests Endoscopic Sleeve Gastroplasty (ESG) using the Apollo OverStitch device. ESG is an FDA-approved procedure aimed at reducing stomach size non-surgically to treat obesity. The trial will be conducted at centers approved by MBSAQIP after IRB authorization.See study design

What are the potential side effects?

Potential side effects may include pain at the procedure site, nausea, vomiting, abdominal bloating or cramps. There could also be risks of infection or rare complications like bleeding or perforation in the stomach wall.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ procedural completion over 10 year period

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~procedural completion over 10 year period

This trial's timeline: 3 weeks for screening, Varies for treatment, and procedural completion over 10 year period for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of participants with technically successful completion of the ESG procedure

Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

Secondary outcome measures

Change in body mass index (BMI) measured by kg/m2

Change in hemoglobin A1C (%)

Trial Design

1Treatment groups

Experimental Treatment

Group I: ESG ProcedureExperimental Treatment2 Interventions

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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

The Methodist Hospital Research InstituteLead Sponsor

274 Previous Clinical Trials

80,385 Total Patients Enrolled

1 Trials studying Obesity

37 Patients Enrolled for Obesity

Thomas R McCarty, MD, MPHPrincipal InvestigatorThe Methodist Hospital Research Institute

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current number of participants involved in this research trial?

"Yes, as per clinicaltrials.gov, this clinical trial is actively seeking participants. The trial was initially listed on February 28, 2024, and last updated on March 24, 2024. The study aims to enroll 150 patients distributed across 2 sites."

Answered by AI

Are there any available positions for patients to participate in this clinical trial?

"Indeed, information from clinicaltrials.gov shows that this research study is actively seeking eligible participants. The trial was first listed on February 28, 2024, and the most recent update was on March 24, 2024. Enrollment aims to recruit 150 individuals from two designated sites."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Endoscopic Sleeve Gastroplasty (ESG) for the Treatment of Obesity

Thomas R McCarty, MD, MPH 2024. "Endoscopic Sleeve Gastroplasty (ESG) for the Treatment of Obesity". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06339320.

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