Clinical trial

ENDOPLY System in Humans: a Pilot Study

Recruiting now · Not applicable · 1 countries · Registry ID NCT06292728

Recruiting nowNot applicableInterventional

What this study 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

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 60 Years

SexAll

Healthy volunteersNot accepted

ConditionObesity

Full registry 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

Treatments and study arms

ENDOPLY System

Device

One endoscopic procedure where the ENDOPLY System is used for endoscopic gastric plication.

Primary outcomes

Time of duration of the ENDOPLY System study procedureDay 1 - Study Procedure

Median range of duration of the ENDOPLY System study procedure (hours).

Number of ligatures placed by ENDOPLY System study procedureDay 1 - Study Procedure

Mean number of ligatures placed by ENDOPLY System study procedure (mean absolute value)

Gastric perforation events12 months

Number of adverse events related to gastric perforation events (absolute value)

Gastrointestinal bleeding events12 months

Number of adverse event related to gastrointestinal bleeding events (absolute value)

Initial weight-loss12 months

Mean weight loss at timepoints: initial assessment and at 1, 3, 6, 12 months (absolute value of mean weight reduction)

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Fakultní nemocnice u sv. Anny v Brně, Gastroenterologické a hepatologické oddělení🇨🇿 Brno, Czechia

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Jan Martínek, prof,MD,PhDContact

Evžen Machytka, MD,PhDContact

Jan Martínek, prof,MD,PhDPrincipal Investigator