Status:
ACTIVE_NOT_RECRUITING
The AUDACITY Study (AllUrion Device in Adults With Clinical ObesITY)
Lead Sponsor:
Allurion Technologies
Conditions:
Obesity
Eligibility:
All Genders
22-65 years
Phase:
NA
Brief Summary
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 t...
Detailed Description
Prospective, open-label, multi-center, randomized study comparing the AGBS + moderate intensity lifestyle modification therapy program vs. moderate intensity lifestyle modification therapy program for...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
- Prescription or over-the- counter weight loss medication known to cause significant weight gain or weight loss within 90 days of study enrollment through study participation
- Uncontrolled or severe psychiatric disease other than mild depression with a patient health questionnaire score of 9 or below
- History of pulmonary embolism or deep venous thrombosis
- Has cardiac pacemaker or other electric implantable device
- Anemia defined as either:
- Hgb \<11 g/dL for females, \<12 g/dL for males
- Cessation of any nicotine product within 3 months of enrollment or plans to quit use during the study
- Documented total body weight loss of ≥ 5% anytime 6 months preceding enrollment
- Residing in a location without access to study site medical resources
- History of or currently active eating disorders including night eating syndrome (NES), bulimia, or binge eating disorder
- Unwilling to refrain from any reconstructive and/or cosmetic surgery that may affect body weight during the study such as mammoplasty and lipoplasty
- Current, or history of, illicit drug use (defined per state law) or excessive alcohol use
- Enrolled in another investigational study that has not completed the required primary endpoint follow-up period (Note: Subjects involved in a long-term surveillance phase of another study are eligible for enrollment in this study).
- 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.
- Any conditions that, in the opinion of each site investigator, may render the subject unable to complete the study with a likely final outcome, or lead to difficulties for subject compliance with study requirements, or could confound study data.
- Subject is not of sufficient medical health as determined by the Investigator to participate in the study.
- Employees/family members of Allurion Technologies or any of its affiliates or contractors
- Immediate employees/family members of the Investigator, sub- Investigators, or their medical office or practice, or surgical, bariatric or hospital organizations at which study procedures may be performed
- An immediate family member (by marriage or blood relationship) of another subject already enrolled in the study
- Positive breath or stool test for H. Pylori
- History of covid-19 with any residual symptoms
- Known or suspected allergies to polyurethane
- Uncontrolled high blood pressure defined as ≥160/100 mmHg with or without medications
- Uncontrolled high cholesterol or triglycerides defined as LDL ≥190 mg/dL or triglycerides ≥500 mg/dL
- Inability to swallow Allurion Practice Capsule
Key Trial Info
Start Date :
May 12 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2025
Estimated Enrollment :
1000 Patients enrolled
Trial Details
Trial ID
NCT05368259
Start Date
May 12 2022
End Date
March 1 2025
Last Update
October 26 2024
Active Locations (17)
Enter a location and click search to find clinical trials sorted by distance.
1
HonorHealth Research Institute
Scottsdale, Arizona, United States, 85258
2
Cedars-Sinai
Los Angeles, California, United States, 90048
3
University of Colorado, Anschutz Health and Wellness Center
Aurora, Colorado, United States, 80045
4
University of Miami, Miller School of Medicine
Doral, Florida, United States, 33166