The AUDACITY Study (AllUrion Device in Adults With Clinical ObesITY)

Running, not enrolling · Not applicable

Conditions studied: Obesity

In brief

The objective for this clinical study is to provide FDA with clinical evidence regarding the effectiveness and safety of the AGBS + moderate intensity lifestyle modification therapy program, indwell time of the AGBS inside the stomach, and outcomes at 48 weeks.

Key facts

Study ID

NCT05368259

Run by

Allurion Technologies

People needed

1000

Starts

2022-05-12

Expected to finish

2025-03-01

Last updated by the study team

2024-10-26

Who can join

Age: 22 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Age ≥22 years and ≤ 65 years of age
• BMI ≥30 kg/m2 and ≤ 40 kg/m2
• Have signed study-specific Informed Consent Form
• Willing to comply with study requirements, including follow-up visits
• Documented negative pregnancy test in women of childbearing potential
• 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).
• Fully ambulatory without any severe chronic orthopedic disease that requires reliance on crutches, walkers, or a wheelchair that could preclude exercise during the study
• At least one unsuccessful attempt at weight loss, such as self-administered, commercial, or medically supervised lifestyle therapy program attempted within the 24 months preceding enrollment

You may not qualify if…

• Unable to walk 400 meters (the length of one loop of a track and field race track) without the use of an assistance device (e.g. cane, crutches, walker, wheel chair)
• Symptomatic congestive heart failure, cardiac arrhythmia or unstable coronary artery disease
• Pre-existing significant respiratory disease such as chronic obstructive pulmonary disease (COPD), severe sleep apnea and pneumonia
• Previous bariatric surgery including adjustable gastric band and endoscopic sleeve gastroplasty, or likely to undergo bariatric surgery during the study period
• Previous use of an intragastric gastric balloon
• Current use of an intragastric device, PlenityTM and digital weight loss solutions (e.g. Noom or Calibrate)
• History of any cancer other than non-melanoma skin cancer or papillary thyroid cancer within the last 5 years
• Benign or malignant gastrointestinal tumors
• History of chronic pancreatitis or acute pancreatitis within 12 months of enrollment
• History of, or current, small bowel obstruction
• History of severe GI motility disorder, such as severe gastroparesis
• History of any esophageal, gastric, or small bowel surgery
• History of, or current inflammatory bowel disease
• Any history of intraperitoneal adhesions
• Any history of open abdominal or gynecological surgery and/or radiation therapy to the abdomen, with the exception of cesarean sections performed at least 12 months prior to study enrollment
• History of/or signs and symptoms of/or radiographic evidence of esophageal, gastric, or duodenal disease including, but not limited to hiatal hernia ≥5cm, inflammatory diseases, varices, severe gastroparesis, recent history of gastric or duodenal ulcers, stricture/stenosis, achalasia, severe GERD requiring maximal medical therapy, or LA Grade B, C, or D esophagitis
• Diagnosis of autoimmune connective tissue disorder (e.g. lupus, erythematous, scleroderma)
• Immunocompromised due to medications or medical disease or diagnosed with HIV
• History of genetic or endocrine causes of obesity not adequately controlled by medication, including hypothyroidism
• Type 1 diabetes or Type 2 diabetes with HgbA1c ≥ 7%, or treated with any anti-diabetic medications other than metformin
• Significant acute and/or chronic infections
• Severe coagulopathy defined as INR 1.5 or higher or platelet count <150, hepatic insufficiency, or cirrhosis
• Unable or unwilling to discontinue use of aspirin and/or nonsteroidal anti-inflammatory agents (NSAIDs) at least 7 days prior to Allurion Deployment and continuing for 7 days after the Allurion Balloon is excreted
• Currently taking the following medications (within 30 days prior to enrollment) and/or there is a need or anticipated need for these medications during the study: Excluded Medications Systemic corticosteroids Anticoagulant therapy (e.g., warfarin, dabigatran) or anti-platelet therapy Immunosuppressive therapy (e.g., azathioprine, cyclosporine) Narcotics, opiates, or benzodiazepines Insulin for treatment of diabetes Anti-seizure therapy (e.g., clonazepam, phenytoin) Anti-arrhythmics (e.g., amiodarone)
• Inability or unwillingness to take anti-emetics during the device residence

Where it is running

• HonorHealth Research Institute — Scottsdale, Arizona, United States
• Cedars-Sinai — Los Angeles, California, United States
• University of Colorado, Anschutz Health and Wellness Center — Aurora, Colorado, United States
• University of Miami, Miller School of Medicine — Doral, Florida, United States
• Chicago Institue of Advanced Surgery — Chicago, Illinois, United States
• Indiana University — Indianapolis, Indiana, United States
• Tufts Medical Center — Boston, Massachusetts, United States
• Lahey Hospital and Medical Center — Burlington, Massachusetts, United States
• Saint Luke's Hospital Kansas City — Kansas City, Missouri, United States
• Washington University — St Louis, Missouri, United States
• University of Nebraska Medical Center — Omaha, Nebraska, United States
• Northwell Health — New Hyde Park, New York, United States
• Atrium Health Care — Charlotte, North Carolina, United States
• University of Pittsburg Medical Center — Pittsburgh, Pennsylvania, United States
• Vanderbilt Center for Surgical Weight Loss — Nashville, Tennessee, United States
• UT Health Science Center at Houston — Bellaire, Texas, United States
• Segar MD — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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