ENDOPLY System in Humans: a Pilot Study
Recruiting · NCT06292728 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
ENDOPLY System
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
Who can take part
Age range
18 Years to 60 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- BMI 30-40, i.e. class I and II obese patients
- Age above 18 and below 60 years
- Having failed multiples diet attempts
Exclusion criteria
- Achalasia and other oesophageal motility disorders
- Severe esophagitis
- Gastroduodenal ulcer
- Heart disease and hypertension without treatment
- Pulmonary, renal or hepatic failure, cancer
- Pregnancy ongoing, scheduled or in the past months
- Previous bariatric surgery or endoscopic bariatric technique
- Participation to another study
Where it is running
1 location listed.
- Fakultní nemocnice u sv. Anny v Brně, Gastroenterologické a hepatologické oddělení - Brno, Czechia