Actively Recruiting
ENDOPLY System in Humans: a Pilot Study
Led by ENDOPLY · Updated on 2025-02-25
10
Participants Needed
1
Research Sites
203 weeks
Total Duration
On this page
Sponsors
E
ENDOPLY
Lead Sponsor
J
Just 4 Device s.r.o.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
ENDOPLY System in Humans: a Pilot Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Body mass index (BMI) between 30 and 40 (class I and II obesity)
- Age above 18 and below 60 years
- History of multiple unsuccessful diet attempts
You will not qualify if you...
- Achalasia or other esophageal motility disorders
- Severe esophagitis
- Gastroduodenal ulcer
- Untreated heart disease or hypertension
- Pulmonary, renal, or hepatic failure
- Cancer
- Current, planned, or recent pregnancy
- Previous bariatric surgery or endoscopic bariatric procedure
- Participation in another clinical study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Fakultní nemocnice u sv. Anny v Brně, Gastroenterologické a hepatologické oddělení
Brno, Czechia, 60200
Actively Recruiting
Research Team
J
Jerome Dargent, MD
CONTACT
J
Jitka Macháčková, M.Sc.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DEVICE_FEASIBILITY
Number of Arms
1
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