Safety and feasibility of the ENDOPLY system in humans: a pilot study
NCT ID NCT06292728
First seen Sep 10, 2026 · Last updated Sep 10, 2026
Summary
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
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 10 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2025
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 60 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Fakultní nemocnice u sv. Anny v Brně, Gastroenterologické a hepatologické oddělení
RECRUITINGBrno, 60200, Czechia
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