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Can a new endoscopic device fold the stomach to fight obesity?

NCT ID NCT06292728

Disease control Sponsor: ENDOPLY Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 10, 2026 · Last updated Sep 11, 2026 · Updated 1 time

Summary

Researchers test a device called the ENDOPLY System that folds the stomach through an endoscope, without surgery. The study enrolls 10 adults with class I or II obesity who have tried multiple diets. Doctors measure how long the procedure takes, how many folds they place, and whether it causes bleeding or perforation. They also track weight loss over a year to see if the approach is safe and feasible.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
ENDOPLY System, an endoscopic device that folds the stomach lining
What this could lead to
If it works, this could offer a less invasive option for weight loss than traditional bariatric surgery.
What could go wrong
This is a small pilot study with 10 people, so it cannot prove the device works or is safe for everyone. Endoscopic stomach procedures carry risks like bleeding or perforation.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

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

About 10 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2025

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

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

18 to 60 years

Sex

Anyone

Healthy volunteers

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

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.

Obesity obesity disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Obesity

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Fakultní nemocnice u sv. Anny v Brně, Gastroenterologické a hepatologické oddělení

    RECRUITING

    Brno, 60200, Czechia

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