Identification of Factors Predictive of the Efficacy of Endoscopic Endoscopic Sleeve Gastroplasty

Launched by ASSISTANCE PUBLIQUE - HÔPITAUX DE PARIS · Nov 30, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at a weight loss procedure called endoscopic sleeve gastroplasty, which is designed for people who are struggling with obesity, particularly those who haven't had success with diet and exercise alone. The goal of the study is to identify which factors can predict how well this treatment will work for different patients. Currently, this procedure is recommended mainly for individuals with a body mass index (BMI) over 35, or those with a BMI between 30 to 35 who have related health issues, like diabetes or sleep apnea. This trial aims to help more people who fall into the lower BMI category but still need assistance with weight loss.

To participate in the trial, you need to be at least 18 years old and have a BMI between 30 and 35 with at least one obesity-related health problem, or a BMI over 35 if you have been denied previous weight-loss surgery. Participants who join the study can expect to receive care and support throughout the process while helping researchers understand how to improve this treatment for future patients. It’s important to note that certain health conditions might exclude you from participating, such as recent antibiotic use or a history of serious stomach issues.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patient of legal age (Age ≥ 18 years)
• • Patient capable of understanding the study and signing a consent.
• • BMI between 30 and 35 kg/m² with the presence of at least one one obesity-related complication (diabetes, dyslipidemia, sleep apnea syndrome, non-alcoholic steatohepatitis, joint pain joint pain).
• • Patients with a BMI greater than 35 kg/m² who have been bariatric surgery has been refused.
• • Patient who has failed to lose weight and improve with conventional techniques.
• • Patient affiliated to a social security scheme
• Exclusion Criteria:
• • Patient having taken antibiotics 3 months prior to inclusion.
• • Patient under legal protection.
• • Patient at risk of gastric cancer requiring regular endoscopic surveillance: extensive intestinal atrophy and/or metaplasia on biopsy.
• • Patient with a history of gastrointestinal inflammatory disease of gastric localization, hepatic or renal insufficiency, portal hypertension.
• • Patient with evidence of peptic ulcer disease and/or progressive peptic ulcer disease.
• • Patient with pathology affecting general health health and/or life expectancy.
• • Patient with a history of bariatric surgery.
• • Patient on AME