Study Summary
This trial is testing a new weight loss program that includes a device placed in the stomach. They want to see if it's effective and safe, and how long the device needs to stay in the stomach.
Treatment Effectiveness
Effectiveness Progress
Study Objectives
2 Primary · 1 Secondary · Reporting Duration: 48 weeks
Trial Safety
Safety Progress
Trial Design
2 Treatment Groups
Moderate Intensity Lifestyle Therapy (CONTROL) Group
1 of 2
AGBS + Moderate Intensity Lifestyle Therapy Group
1 of 2
Active Control
Experimental Treatment
1000 Total Participants · 2 Treatment Groups
Primary Treatment: AGBS · No Placebo Group · N/A
Trial Logistics
Trial Timeline
Who is running the clinical trial?
Eligibility Criteria
Age 22 - 65 · All Participants · 8 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:Who else is applying?
What state do they live in?
| Texas | 50.0% |
| Indiana | 16.7% |
| North Carolina | 8.3% |
| Other | 25.0% |
How old are they?
| 18 - 65 | 100.0% |
What site did they apply to?
| Honor Health | 10.0% |
| University of Colorado, Anschutz Health and Wellness Center | 10.0% |
| BMI Texas | 50.0% |
| Other | 30.0% |
What portion of applicants met pre-screening criteria?
| Met criteria | 83.3% |
| Did not meet criteria | 16.7% |
Why did patients apply to this trial?
- "I’ve tried diets that have not worked. I’d like to try something different to kickstart a weight loss journey"
- "I have long term health goals related to hearth health and longevity that motivate me to lose weight and reach certain health markers in that process."
- "I've been trying for 20+ years to lose weight...fad diets, exercise, lifestyle changes, doctors, weight loss programs, pills, etc. Some methods worked better than others but I have never come close to achieving my goal weight. While I have been able to lose over 100lbs over a 4 year period, I am still struggling, and am, in fact, gaining again. The excess weight is affecting my daily life like it never has before and I need help."
What questions have other patients asked about this trial?
- "How long do screening visits take and how often?"
How many prior treatments have patients received?
| 0 | 66.7% |
| 3+ | 33.3% |
Frequently Asked Questions
Could individuals aged over 55 participate in this clinical investigation?
"As per the trial conditions, no one younger than 22 years old or older than 65 will be accepted for this clinical study." - Anonymous Online Contributor
Are there plentiful sites within the US hosting this clinical experiment?
"This medical trial is being conducted at UT Physicians Minimally Invasive Surgeons of Texas (UTMIST) in Bellaire, New York, Stony Brook Surgical Associates in Stony Brook, Missouri and Washington University in Saint Louis Tennessee to name but a few out of the additional 10 sites." - Anonymous Online Contributor
To what demographic of people is this clinical trial open?
"The requirements for consideration in this medical trial are an age between 22 and 65 years old, as well as a BMI above the obesity threshold. The goal is to recruit approximately 1000 participants." - Anonymous Online Contributor
To what extent have people taken part in this medical experiment?
"1000 volunteers, meeting the predetermined parameters for inclusion in this study, are needed to participate. UTMIST Bellaire and Stony Brook Surgical Associates offer clinical trial services from their respective locations in Texas and Missouri." - Anonymous Online Contributor
Is recruitment still occurring for this research project?
"Based on the current listings on clinicaltrials.gov, this study is in a period of active recruitment. It was initially added to the database on May 12th 2022 and edited most recently on November 26th 2022." - Anonymous Online Contributor