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New stomach wrap could improve gastric bypass results and reduce reflux

NCT ID NCT04834635

Disease control Sponsor: The Society of Bariatric and Metabolic Surgeons of Kazakhstan Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a new surgical technique called FundoRing, where the surgeon wraps the unused part of the stomach around the new stomach pouch during gastric bypass. The goal is to improve weight loss and reduce bile reflux compared to the standard bypass. One thousand adults with obesity were randomly assigned to get either the FundoRing or standard surgery, and researchers tracked their weight, reflux symptoms, and complications over time.

What this could mean

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

Active substance
surgical procedure (FundoRing gastric bypass)
What this could lead to
If successful, this new surgical technique could improve long-term weight loss and reduce bile reflux after gastric bypass, without using foreign materials that can cause complications.
What could go wrong
This is a completed trial, but the results are not yet widely known. The procedure is still experimental and may not prove better than the standard approach; there are also typical surgical risks like infection or complications.

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

1,000 people

The number who actually took part.

Started

Mar 2021

Finished

May 2026

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: * BMI from 30 to 50 kg / m2. * The person is generally fit for anesthesia (ASA grading 1-2) and surgery. * The person commits to the need for long-term follow-up. Exclusion Criteria: * BMI less than 30 kg / m2 and more than 50 kg / m2. * Prosthetic (mesh) Hiatal herniorrhaphy or large hiatal hernia; * Esophageal shortening * Los Angeles Classification of Oesophagitis (LA grade) C or D reflux esophagitis * History of surgery on the stomach or esophagus * Less than 18 or more than 60 years of age * Not fit for bariatric surgery * Psychiatric illness * Patients unwilling or unable to provide informed consent

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Conditions

The condition(s) this trial relates to.

morbid obesity Obesity obesity disorder

As listed by the trial registrant

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

Obesity, morbid

Contacts and locations

Locations

  • Oral Ospanov

    Astana, 010000, Kazakhstan

More trials for these conditions

Other studies related to the condition(s) this trial covers.