Endoscopic Sleeve Gastroplasty (ESG) for the Treatment of Obesity

Launched by THE METHODIST HOSPITAL RESEARCH INSTITUTE · Mar 24, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a procedure called Endoscopic Sleeve Gastroplasty (ESG) to help people with obesity lose weight. ESG is a minimally invasive procedure approved by the FDA for individuals with a body mass index (BMI) between 30 and 50 kg/m² who have struggled to lose weight through diet and exercise alone. The trial is currently recruiting participants, and it welcomes individuals of all genders between the ages of 65 and 74.

To be eligible for the trial, participants must have a BMI within the specified range and have tried other weight loss methods without success. However, certain conditions may exclude individuals from participating, such as being pregnant, using tobacco recently, or having specific medical issues like active ulcers or certain psychiatric disorders. If you join the trial, you can expect to undergo the ESG procedure, which aims to assist with weight loss, and you will be closely monitored by medical professionals throughout the process.

Gender

ALL

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 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