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ENDOPLY System in Humans: a Pilot Study

RecruitingNA

Sponsor: ENDOPLY

Conditions: Obesity

Interventions: ENDOPLY System

Countries: Czechia

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 overview

Sex: ALL

Age: 18 Years to 60 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

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

Locations (1)

Brno, Czechia