NCT06292728 ENDOPLY System in Humans: a Pilot Study
| NCT ID | NCT06292728 |
| Status | Recruiting |
| Phase | — |
| Sponsor | ENDOPLY |
| Condition | Obesity |
| Study Type | INTERVENTIONAL |
| Enrollment | 10 participants |
| Start Date | 2022-01-09 |
| Primary Completion | 2025-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 10 participants in total. It began in 2022-01-09 with a primary completion date of 2025-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Prospective, non-randomized study aimed at defining the initial pattern of gastric plication with the ENDOPLY System, and assess feasibility, ergonomics and safety of the device Prospective, single-centre, open label, consecutive enrolment
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
Contact & Investigator
Jerome Dargent, MD
STUDY DIRECTOR
CEO, chief executive
Frequently Asked Questions
Who can join the NCT06292728 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 60 Years, studying Obesity. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06292728 currently recruiting?
Yes, NCT06292728 is actively recruiting participants. Contact the research team at jerome.dargent@polyclinique-rillieux.fr for enrollment information.
Where is the NCT06292728 trial being conducted?
This trial is being conducted at Brno, Czechia.
Who is sponsoring the NCT06292728 clinical trial?
NCT06292728 is sponsored by ENDOPLY. The principal investigator is Jerome Dargent, MD at CEO, chief executive. The trial plans to enroll 10 participants.
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