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Gastric Balloon

Gastric Balloon for Obesity (AUDACITY Trial)

N/A
Waitlist Available
Research Sponsored by Allurion Technologies
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age ≥22 years and ≤ 65 years of age
Women of childbearing potential not intending to become pregnant for the duration of study participation. (Note: Women of childbearing potential must not be nursing at the time of treatment)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 48 weeks
Awards & highlights

AUDACITY Trial 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.

Who is the study for?
Adults aged 22-65 with a BMI between 30 and 40, who have tried and failed to lose weight in the past two years. Participants must be able to exercise without assistance devices, not pregnant or nursing, fully vaccinated against COVID-19, and willing to follow study procedures.Check my eligibility
What is being tested?
The AUDACITY Study is testing the safety and effectiveness of AGBS (a device placed inside the stomach) combined with a moderate intensity lifestyle modification program over a period of 48 weeks in adults struggling with obesity.See study design
What are the potential side effects?
Potential side effects are not explicitly listed but may include discomfort from the device placement procedure, digestive issues due to the presence of AGBS in the stomach, and possible nutritional deficiencies from altered eating patterns.

AUDACITY Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 22 and 65 years old.
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I am not planning to get pregnant and will not nurse during the study.
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I can walk without help from devices and don't have severe joint diseases.

AUDACITY Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~48 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 48 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
%TBWL is significantly greater than Control Group mean %TBWL at 48 weeks
Responder Rate (RR) dichotomized at 5% TBWL at 48 week
Secondary outcome measures
Responder Rate (RR) dichotomized at both 5% and 10% TBWL at both 16 and 24 weeks
Other outcome measures
Change in body fatness as measured by Body Mass Index (BMI) at 24 and 48 weeks
Change in metabolic parameters
RR dichotomized at 10% TBWL at both 40 and 48 weeks

AUDACITY Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: AGBS + Moderate Intensity Lifestyle Therapy GroupExperimental Treatment1 Intervention
Patients randomized to treatment will receive the AGBS device
Group II: Moderate Intensity Lifestyle Therapy (CONTROL) GroupActive Control1 Intervention
Patients randomized to the control arm will receive moderate-intensity lifestyle therapy.

Find a Location

Who is running the clinical trial?

Allurion TechnologiesLead Sponsor
3 Previous Clinical Trials
549 Total Patients Enrolled
3 Trials studying Obesity
549 Patients Enrolled for Obesity

Media Library

Obesity Clinical Trial 2023: AGBS Highlights & Side Effects. Trial Name: NCT05368259 — N/A
AGBS (Gastric Balloon) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05368259 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

Who else is applying?

What state do they live in?
North Carolina
Missouri
Other
Texas
How old are they?
18 - 65
What site did they apply to?
BMI Texas
HonorHealth Research Institute
Cedars-Sinai
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
2
1
0
3+

Why did patients apply to this trial?

Want to lose 15% of my current weight. I have tried other drugs without success.
PatientReceived no prior treatments
I am overweight and struggle to maintain consistent weight. I really need to lose weight my legs and back and ankles hurts so bad.
PatientReceived 2+ prior treatments
I've tried other ways of losing weight now I'm hoping a clinical trial can help me!
PatientReceived no prior treatments

What questions have other patients asked about this trial?

Is this a paid trial? How long do the screen visits take? How long do screening visits take and how often?
PatientReceived 2+ prior treatments
How I know if I qualify and what benefits I receive in case of be elegible?
PatientReceived 1 prior treatment
I expect to lose time from work. Is there any compensation to offset travel and lost time from work?
PatientReceived 2+ prior treatments

How responsive is this trial?

Most responsive sites:
  1. Washington University: < 48 hours
Typically responds via
Email
Average response time
  • < 2 Days
Recent research and studies
clinicaltrials.govStudy
The AUDACITY Study (AllUrion Device in Adults With Clinical ObesITY)
2022. "The AUDACITY Study (AllUrion Device in Adults With Clinical ObesITY)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05368259.
~343 spots leftby Apr 2025
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