Using the ENDOPLY System for gastric plication in obese patients
Safety and Feasibility of the ENDOPLY System in Humans: a Pilot Study
This study is testing a new device called the ENDOPLY System to see if it can safely help obese patients lose weight by reducing the size of their stomachs through a special procedure.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | Endoply Academic / other |
| Locations | 1 site (Brno) |
| Trial ID | NCT06292728 on ClinicalTrials.gov |
What this trial studies
This pilot study evaluates the feasibility, ergonomics, and safety of the ENDOPLY System for endoscopic gastric plication in obese patients. It involves a prospective, non-randomized approach with a single center enrolling 10 participants who are classified as grade I and II obese. The procedure is performed under general anesthesia, where ligatures are placed to reduce gastric volume, potentially aiding in weight loss. The study aims to gather clinical data that could expand the use of this medical device in obesity treatment.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 60 with a BMI between 30 and 40 who have struggled with multiple diet attempts.
Not a fit: Patients with severe esophageal disorders, heart disease, or those who have undergone previous bariatric surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a new method for weight loss that improves health and quality of life for obese patients.
How similar studies have performed: While this approach is novel, similar endoscopic techniques have shown promise in treating obesity in other studies.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Brno
- Fakultní nemocnice u sv. Anny v Brně, Gastroenterologické a hepatologické oddělení — Brno, Czechia (Recruiting)
Study contacts
- Study coordinator: Jerome Dargent, MD
- Email: jerome.dargent@polyclinique-rillieux.fr
- Phone: 0033681472286
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.