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NCT04306445 · ClinicalTrials.gov registry record · NA
How Gas-Filled Intragastric Balloons or Endoscopic Sleeve Gastroplasty Affect Hunger, Hunger Hormones, and Gastric Emptying Compared to Meal Replacements
A NA study, sponsored by University of Colorado, Denver.
- Terminated
- Registry status
- NA
- Development phase
- 3
- Enrollment target
NCT04306445: Clinical Trial NA study, sponsored by University of Colorado, Denver.
NCT04306445 is a NA study that was terminated before completion, run by University of Colorado, Denver. The registered enrollment target is 3 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04306445, a NA study, was terminated before completion, sponsored by University of Colorado, Denver.
- TERMINATED
- Registry status
- NA
- Development phase
- 3 participants
- Enrollment target
Study Summary
The disease obesity continues to be a major health issue in the US with over one third of the population having a mass index \>30 kg/m2. Obesity is associated with serious cardiometabolic complications including diabetes, hypertension, dyslipidemia and myocardial infarction. Rates of successful obesity treatment with weight loss and weight maintenance remain low. Several endoscopic bariatric therapies and procedures have been approved for use in the United States, including three intragastric balloon systems (2 fluid-filled and one gas-filled) and endoscopic sleeve gastroplasty (ESG), both of which have lower risks than bariatric surgery and do not alter gastrointestinal anatomy. Weight loss with all intragastric balloons and ESG is higher than lifestyle therapy or weight loss medications, but less than bariatric surgery. Unlike weight loss medications where weight loss from the medication is regained within 6-8 months after therapy ends, weight loss maintenance with intragastric balloons remains high with 66-88.5% of the weight loss maintained 6 months after device removal. Data suggests that space occupying devices with a volume of 400 ml or more in the stomach increase feelings of fullness and result in weight loss, but this does not explain the prolonged effect of weight loss maintenance after balloon removal. Although few studies have investigated the mechanism of action of fluid-filled balloons and one study with 4 patients undergoing ESG on weight loss, these data suggest that gastric emptying as well as space occupation contribute to weight loss. However, no studies have investigated the mechanisms of action of gas filled intragastric balloons on weight loss. Understanding the mechanisms responsible for weight loss with the gas filled intragastric balloon system and ESG as well as any weight loss independent effects on blood glucose control would lay the groundwork for studies evaluating predictors of response to improve patient selection as well as studies
Primary Outcome
10%TBWL by GI-IGB, ESG, or Medically Supervised MRP
Interventions
- DEVICE GF-IGB: Obalon Balloon
- DIETARY_SUPPLEMENT Medically Supervised Meal Replacement Program: My New Weigh
- PROCEDURE Endoscopic sleeve gastroplasty: (ESG)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3 participants |
| Start Date | 2020-03-02 |
| Est. Completion | 2024-02-22 |
| Phase | NA |
Why NCT04306445 stopped before completion
NCT04306445 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 3 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower).
The record links to 0 conditions, and to 3 interventions - of which GF-IGB: Obalon Balloon is the first listed.
NCT04306445 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04306445 about?
NCT04306445 is a clinical study titled "How Gas-Filled Intragastric Balloons or Endoscopic Sleeve Gastroplasty Affect Hunger, Hunger Hormones, and Gastric Emptying Compared to Meal Replacements". The disease obesity continues to be a major health issue in the US with over one third of the population having a mass index \>30 kg/m2. Obesity is associated with serious cardiometabolic complications including diabetes, hypertension, dyslipidemia and myocardial infarction. Rates of successful obes...
What is the current status of trial NCT04306445?
This trial is currently terminated. It is a NA study. The enrollment target is 3 participants. The study started on 2020-03-02. Estimated completion is 2024-02-22.
What interventions are being tested in trial NCT04306445?
The interventions under investigation include: GF-IGB: Obalon Balloon (DEVICE), Medically Supervised Meal Replacement Program: My New Weigh (DIETARY_SUPPLEMENT), Endoscopic sleeve gastroplasty: (ESG) (PROCEDURE).
Who is sponsoring clinical trial NCT04306445?
This trial is sponsored by University of Colorado, Denver, which has 1,283 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04306445's enrollment target sits among peer trials
3 1996th of 2000 higher than 4 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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