ENDOPLY System in Humans: a Pilot Study

Launched by ENDOPLY · Mar 1, 2024

Keywords

ClinConnect Summary

The ENDOPLY System in Humans trial is a study designed to explore a new approach to help people with obesity. Specifically, the researchers are looking into a method called gastric plication, which involves folding part of the stomach to help limit food intake and promote weight loss. This is a pilot study, meaning it's an early investigation to see how well the device works, how safe it is, and how easy it is to use. The study is currently recruiting participants aged 18 to 60 who have a body mass index (BMI) between 30 and 40 and have struggled with weight loss through diet alone.

Participants in this trial can expect to undergo the procedure with the ENDOPLY System and will be monitored closely for any safety concerns or issues. However, not everyone can join; people with certain health conditions, like severe heart problems or recent pregnancy, as well as those who have had previous weight loss surgeries, cannot participate. This study is an important step in finding new solutions for obesity, offering hope to those who have not had success with traditional weight loss methods.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. BMI 30-40, i.e. class I and II obese patients
• • 2. Age above 18 and below 60 years
• • 3. Having failed multiples diet attempts
• Exclusion Criteria:
• • 1. Achalasia and other oesophageal motility disorders
• • 2. Severe esophagitis
• • 3. Gastroduodenal ulcer
• • 4. Heart disease and hypertension without treatment
• • 5. Pulmonary, renal or hepatic failure, cancer
• • 6. Pregnancy ongoing, scheduled or in the past months
• • 7. Previous bariatric surgery or endoscopic bariatric technique
• • 8. Participation to another study