Clinical trial for Endoscopic Sleeve Gastroplasty
Official title Endoscopic Sleeve Gastroplasty (ESG) for the Treatment of Obesity
ClinicalTrials.gov ID: NCT06339320
What this study is testing
- What it's testing
- The study aims to evaluate how well the endoscopic sleeve gastroplasty (ESG) procedure works for treating obesity.
- Who it's for
- The study is looking for people with a body mass index (BMI) between 30 and 50.
- What's involved
- Participants will undergo the ESG procedure, which is a method to shrink the stomach using a scope.
- Time commitment
- The source text does not specify the total duration or number of visits required.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
You likely can't join if
- 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
See the full eligibility 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.
- 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...
- Patients with endoscopic interventions that are contraindicated
The study team makes the final eligibility decision.
Where it is enrolling
- Houston, Texas, United States
- Sugar Land, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Houston, Texas, United States; Sugar Land, Texas, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.