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Tiny study probes why stomach balloons and stapling help people lose weight

NCT ID NCT04306445

Knowledge-focused Sponsor: University of Colorado, Denver 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
The trial has finished. Results may not be published yet.
Stopped early This study
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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This study looked at how gas-filled stomach balloons and a procedure called endoscopic sleeve gastroplasty affect stomach emptying, hunger hormones, and appetite in people with obesity. Researchers compared these treatments to a meal replacement program. The goal was to understand the mechanisms behind weight loss, not to test a new treatment. Only 3 people were enrolled before the study was stopped.

What this could mean

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

Active substance
Obalon Balloon (gas-filled intragastric balloon) and endoscopic sleeve gastroplasty
What this could lead to
If successful, this could help doctors understand why these weight loss procedures work, potentially leading to better patient selection and longer-lasting results.
What could go wrong
This was a very small pilot study (only 3 participants) that was terminated early, so results are limited and may not apply to the general population.

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

3 people

The number who actually took part.

Started

Mar 2020

Finished

Feb 2024

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

22 to 65 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: * Male and female participants aged 22-65 * Weight Stable (\<5% weight change in the last 3 months) * Initiating treatment with GF-IGB, ESG, or medically supervised MRP * BMI of 30-40 Exclusion Criteria: * History of liver disease * History of uncontrolled thyroid disease * History of anemia * History of diabetes * History of eating disorder * History of uncontrolled depression defined as a score of ≥ 10 on PHQ-9 (Patient Health Questionnaire-9) * Use of weight loss medications in the past 3 months * History of gastroparesis * History of bariatric surgery * History to allergy or intolerance to any component of the meal used in the gastric emptying study or mixed meal test * Women who are pregnant or lactating * Currently incarcerated * Non English speaking * Decisionally challenged adults

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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

Contacts and locations

Locations

  • University of Colorado

    Aurora, Colorado, 80045, United States

More trials for these conditions

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