No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
18 and older
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
150 (estimated)
Sponsor
The Methodist Hospital Research Institute · Other
Who this trial is looking for
This trial is looking for individuals seeking help with obesity through a procedure called endoscopic sleeve gastroplasty. Participants should have tried other weight loss methods without success.
Are You a Good Fit for This Trial?
You may be able to join if
I have a body mass index (BMI) between 30 and 50
I have struggled to lose weight or keep it off through diet and exercise
You may not be able to join if
I am currently pregnant
I smoke tobacco and have done so in the past 4 weeks
I have active stomach ulcers or other serious stomach issues
I have any type of stomach or bowel cancer
I have a large hiatal hernia (larger than 5 cm)
I have severe bleeding problems that cannot be fixed
I have not been evaluated by a mental health professional for my psychiatric disorders
I have previous endoscopic procedures that are not allowed
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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…
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).
Trial Locations
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City
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Status
Eligibility Criteria
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 intervention…
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
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