ENDOPLY System in Humans: a Pilot Study
Recruiting
N/A
Interventional Study
Obesity
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 18 – 60
- Sex
- Any
- Study type
- Interventional
- Purpose
- Device Feasibility
- Participants needed
- 10 (estimated)
- Sponsor
- ENDOPLY · Other
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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
Trial Locations
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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 hypertensio…
Contacts