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Can a stomach band boost weight loss in the most severe obesity?

NCT ID NCT07100327

Disease control Sponsor: General Committee of Teaching Hospitals and Institutes, Egypt 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 11, 2026 · Last updated Sep 11, 2026

Summary

Researchers compare two weight-loss operations in adults with Class IV obesity, defined as a body mass index of 50 or higher. One group receives standard sleeve gastrectomy, where surgeons remove most of the stomach. The other receives the same operation plus a polypropylene band placed around the upper stomach pouch to add restriction. The trial follows participants for three years to measure total weight loss and changes in related conditions such as type 2 diabetes.

What this could mean

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

Active substance
Banded sleeve gastrectomy, a weight-loss operation that adds a polypropylene band around the top of the stomach pouch
What this could lead to
If the banded version works better, it could become a preferred option for people with the most severe obesity who need lasting weight loss.
What could go wrong
The band can slip, erode, or cause reflux, and any surgery carries risks. Weight loss may not differ between the two groups, and results in Egypt may not apply everywhere.

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

219 people

The number who actually took part.

Started

Jun 2022

Finished

Jul 2025

Lead sponsor

A government agency

The lead sponsor is a government body.

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: * Adults aged 18-60 years * BMI ≥ 50 kg/m² (Class IV obesity) * No prior gastrointestinal surgeries * No significant psychiatric or medical contraindications to surgery * Ability to provide informed consent Exclusion Criteria: * BMI \< 50 kg/m² * Refusal to undergo band placement * Active reflux disease or PPI use * Prior bariatric surgery * Pregnancy plans during the study period * Active cancer or life-limiting illness * Substance abuse or non-compliance with postoperative care * Gastroesophageal reflux disease. * Hiatal hernia.

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Conditions

The condition(s) this trial relates to.

morbid obesity

As listed by the trial registrant

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

Morbid obesity requiring bariatric surgery

Contacts and locations

Locations

  • The surgical department of Medical Research Institute Hospital, Alexandria University

    Alexandria, 21531, Egypt

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