RECRUITINGINTERVENTIONAL
ENDOPLY System in Humans: a Pilot Study
Safety and Feasibility of the ENDOPLY System in Humans: a Pilot Study
About This Trial
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 May Be Eligible (Plain English)
Who May Qualify:
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
Who Should NOT Join This Trial:
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
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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
Treatments Being Tested
DEVICE
ENDOPLY System
One endoscopic procedure where the ENDOPLY System is used for endoscopic gastric plication.
Locations (1)
Fakultní nemocnice u sv. Anny v Brně, Gastroenterologické a hepatologické oddělení
Brno, Czechia