What side effects are associated with this type of intervention?

The Swedish Adjustable Gastric Band (SAGB) and similar bariatric procedures primarily involve physical restriction of the stomach to promote weight loss. Common side effects include nausea, vomiting, and abdominal pain. Device-related complications can include band slippage, erosion, and infection. Pharmacological treatments for obesity, such as GLP-1 receptor agonists (e.g., liraglutide, semaglutide), can cause gastrointestinal side effects like nausea and vomiting. Other medications, such as phentermine-topiramate, may lead to increased heart rate, insomnia, and dry mouth. It is important to discuss these potential side effects with a healthcare provider to determine the most appropriate treatment.

What prior FDA approvals exist?

The FDA has approved several treatments for obesity that involve physical restriction of the stomach. One of the most well-known is the laparoscopic adjustable gastric banding (LAGB), which involves placing an adjustable band around the upper part of the stomach to create a small stomach pouch, limiting food intake and promoting weight loss. Other surgical options include the Roux-en-Y gastric bypass and sleeve gastrectomy, which also reduce stomach size and alter digestive processes. In addition to these surgical interventions, the FDA has approved pharmacological treatments such as orlistat, phentermine-topiramate, and liraglutide, which aid in weight loss through different mechanisms but do not involve physical restriction of the stomach.

What other types of research exist?

Promising alternatives to AGBS for obesity treatment in 2024 include: 1) Sleeve Gastrectomy, which involves removing a portion of the stomach to reduce its size and limit food intake. 2) Roux-en-Y Gastric Bypass, which creates a small stomach pouch and reroutes the small intestine to promote malabsorption and restriction. 3) Endoscopic Sleeve Gastroplasty, a less invasive procedure that uses an endoscope to reduce stomach size. 4) Intragastric Balloons, which are temporary devices placed in the stomach to promote a feeling of fullness. These alternatives have shown effectiveness in weight loss and improvement in comorbidities with varying degrees of invasiveness and long-term outcomes.

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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)

Must not have

Current Use (within the last month) of any smoked or non-smoked marijuana products that contain THC or unwilling to abstain from THC containing marijuana products during the trial

Uncontrolled high cholesterol or triglycerides defined as LDL ≥190 mg/dL or triglycerides ≥500 mg/dL

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 48 weeks

Awards & highlights

No Placebo-Only Group

Summary

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.

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.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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

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I have anemia with Hgb levels below the normal range.

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I am currently using a weight loss device or digital program.

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I have had chronic pancreatitis or an episode of acute pancreatitis in the last year.

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I have a history of internal scar tissue in my abdomen.

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I have a tumor in my digestive system.

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I have had a blood clot in my lung or deep veins.

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I have a weakened immune system due to medication, a medical condition, or HIV.

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I have diabetes with HgbA1c ≥ 7% or am on diabetes medication other than metformin.

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I have a serious lung condition like COPD, severe sleep apnea, or pneumonia.

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I have or had inflammatory bowel disease.

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I have had, or currently have, a blockage in my small intestine.

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I have a severe stomach emptying disorder.

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I have had surgery on my esophagus, stomach, or small intestine.

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My obesity is not caused by genetic or hormonal issues, or if so, it's controlled by medication.

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I have had or am likely to have weight-loss surgery during the study.

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I can't walk 400 meters without help like a cane or wheelchair.

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I am currently dealing with a serious infection.

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I have been diagnosed with an autoimmune connective tissue disorder like lupus.

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I have lost 5% or more of my body weight in the last 6 months.

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I cannot or will not stop taking aspirin/NSAIDs for 7 days before and after the Allurion procedure.

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I do not have serious heart problems like heart failure, irregular heartbeat, or unstable heart disease.

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My mental health is stable, with mild or no depression.

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I do not have severe blood clotting issues, liver problems, or cirrhosis.

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I agree not to have any cosmetic surgery that could change my weight during the study.

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I have not had any cancer except for skin or thyroid cancer in the past 5 years.

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I cannot swallow the Allurion Practice Capsule.

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I had COVID-19 and still experience some symptoms.

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I haven't taken weight loss or gain drugs in the last 90 days.

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I stopped using nicotine products 3 months ago or plan to quit during the study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 48 weeks

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

%TBWL is significantly greater than Control Group mean %TBWL at 48 weeks

Responder Rate (RR) dichotomized at 5% TBWL at 48 week

Secondary study objectives

Responder Rate (RR) dichotomized at both 5% and 10% TBWL at both 16 and 24 weeks

Other study objectives

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 34Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The Adjustable Gastric Band System (AGBS) works by physically restricting the stomach's size, which limits food intake and promotes a feeling of fullness with smaller amounts of food. This mechanical restriction helps patients reduce caloric intake, leading to weight loss. Other common treatments include Roux-en-Y gastric bypass and sleeve gastrectomy, which also reduce stomach size and alter gut hormone levels to enhance satiety and reduce hunger. These mechanisms are crucial for obesity patients as they address the fundamental issue of overeating by promoting early satiety and reducing caloric intake, thereby facilitating sustainable weight loss and improving obesity-related comorbidities.

Long-term results of adjustable gastric banding in a cohort of 186 super-obese patients with a BMI≥ 50 kg/m2.Studies of Swedish adjustable gastric band and Lap-Band: systematic review and meta-analysis.