Gastric Balloon for Obesity

(AUDACITY Trial)

Recruiting at 19 trial locations

Overseen By Aurora Pryor, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Allurion Technologies

Must not be taking: Corticosteroids, Anticoagulants, Immunosuppressants, others

Disqualifiers: Heart failure, Respiratory disease, Diabetes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 48 weeks

1000 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a stomach device and a healthy lifestyle program to help adults with obesity lose weight. The device makes people feel full sooner, and the program supports better eating and exercise habits.

Do I need to stop my current medications for the trial?

Yes, you may need to stop certain medications. The trial requires participants to discontinue aspirin, NSAIDs, and several other medications like systemic corticosteroids, anticoagulants, and narcotics at least 7 days before the procedure and during the study.

Is the gastric balloon safe for treating obesity?

The gastric balloon is generally considered safe, but some people experience side effects like nausea, vomiting, and abdominal pain. Serious complications are rare, but can include gastric perforation (a hole in the stomach) and acute pancreatitis (inflammation of the pancreas). ^{1 2 3 4 5}

How is the gastric balloon treatment for obesity different from other treatments?

The gastric balloon treatment is unique because it is a temporary, nonsurgical option that involves placing an inflatable balloon in the stomach to help with weight loss. Unlike more invasive bariatric surgeries, it is minimally invasive and preserves the stomach's anatomy, making it a safer alternative for those who have not had success with other conservative treatments. ^{6 7 8 9 10}

What data supports the effectiveness of the treatment AGBS for obesity?

The intragastric balloon (IB), a component of the AGBS treatment, has been shown to help with weight loss and improve obesity-related health issues. It is particularly effective for people with a body mass index (BMI) between 30 and 40, and can also be beneficial for those preparing for further weight loss surgery. ^{7 10 11 12 13}

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I have tried and failed to lose weight in the past 2 years.

BMI ≥30 kg/m2 and ≤ 40 kg/m2

Willing to comply with study requirements, including follow-up visits

Exclusion Criteria

I have not used marijuana products containing THC in the last month and am willing to abstain during the trial.

My cholesterol or triglycerides levels are not higher than the specified limits.

I have anemia with Hgb levels below the normal range.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the AGBS device and moderate intensity lifestyle modification therapy

48 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• AGBS

Trial Overview 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.

How Is the Trial Designed?

Group I: AGBS + Moderate Intensity Lifestyle Therapy Group Experimental Treatment 1 Intervention

Patients randomized to treatment will receive the AGBS device

Group II: Moderate Intensity Lifestyle Therapy (CONTROL) Group Active Control 1 Intervention

Patients randomized to the control arm will receive moderate-intensity lifestyle therapy.

Who Is Running the Clinical Trial?

Allurion Technologies

Lead Sponsor

Trials

4

Recruited

1,500+

Published Research Related to This Trial

In a study of 190 obese patients undergoing gastric balloon therapy, the average weight loss was 21.2 kg after 6 months, indicating significant efficacy in promoting weight loss for morbidly obese individuals.

The procedure demonstrated a high safety profile, with only minor complications occurring in 2% of cases and no major complications or mortality, making it a viable option for initial obesity treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preoperative weight reduction using the intragastric balloon. Göttig, S., Weiner, RA., Daskalakis, M.[2021]

A review of FDA data from January 2017 to November 2020 identified 773 cases involving intragastric balloons, revealing a total of 1134 patient complications, primarily due to device leaks (33.4%).

The most common adverse events reported were vomiting (26.6%), abdominal pain (25.3%), and nausea (15.8%), indicating significant side effects that need to be managed to enhance the effectiveness of this obesity treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Real-World Experience of Intragastric Balloons for Obesity: Insights from the FDA Manufacturer and User Facility Device Experience (MAUDE) Database. Ramai, D., Bhandari, P., Facciorusso, A., et al.[2021]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

Six months of balloon treatment does not predict the success of gastric banding. [2019]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Preoperative weight reduction using the intragastric balloon. [2021]

3. Switzerland pubmed.ncbi.nlm.nih.gov

[Minimally invasive treatment of obesity with the intragastric balloon: a review]. [2014]

4. United States pubmed.ncbi.nlm.nih.gov

Critical appraisal of salvage banding for weight loss failure after gastric bypass. [2019]

5. Mexico pubmed.ncbi.nlm.nih.gov

Intragastric balloon placement for the management of obesity: improving patient selection. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Real-World Experience of Intragastric Balloons for Obesity: Insights from the FDA Manufacturer and User Facility Device Experience (MAUDE) Database. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Intragastric Balloon for Management of Severe Obesity: a Systematic Review. [2018]

8. England pubmed.ncbi.nlm.nih.gov

Acute pancreatitis as a late complication of intra-gastric balloon insertion. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

Acute Pancreatitis as a Complication of an Intragastric Balloon. [2023]

10. Switzerland pubmed.ncbi.nlm.nih.gov

[The intragastric balloon: a logical and attractive idea, but probably ineffective]. [2012]

11. Italy pubmed.ncbi.nlm.nih.gov

[Treatment of obesity with gastric balloon]. [2007]

12. United States pubmed.ncbi.nlm.nih.gov

Safety and Efficacy of 12-Month Intra-gastric Balloon-Series of over 1100 Patients. [2023]

13. England pubmed.ncbi.nlm.nih.gov

Adjustable intragastric balloon for treatment of obesity: a multicentre, open-label, randomised clinical trial. [2022]