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

M
Mark Gromski, MD

Primary Investigator

Administratively Closed
22 years - 65 years
All
Phase N/A
1000 participants needed
1 Location

Brief description of study

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

Detailed description of study

Prospective, open-label, multi-center, randomized study comparing the AGBS + moderatey lifestyle modification therapy program vs. moderate intensity lifestyledification therapy program for the treatment of adults with obesity.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Obesity
  • Age: 22 years - 65 years
  • Gender: All

Inclusion Criteria:
  1. Age ≥22 years and ≤ 65 years of age
  2. BMI ≥30 kg/m2 and ≤ 40 kg/m2
  3. Have signed study-specific Informed Consent Form
  4. Willing to comply with study requirements, including follow-up visits
  5. Documented negative pregnancy test in women of childbearing potential
  6. Women of childbearing potential not intending to become pregnant for the duration ofudy participation. (Note: Women of childbearing potential must not be nursing at the).
  7. Fully ambulatory without any severe chronic orthopedic disease that requires relianceutches, walkers, or a wheelchair that could preclude exercise during the study
  8. At least one unsuccessful attempt at weight loss, such as self-administered,dically supervised lifestyle therapy program attempted within the 24hs preceding enrollment
Exclusion Criteria:
  1. 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)
  2. Symptomatic congestive heart failure, cardiac arrhythmia or unstable coronary arterydisease
  3. Pre-existing significant respiratory disease such as chronic obstructive pulmonarydisease (COPD), severe sleep apnea and pneumonia
  4. Previous bariatric surgery including adjustable gastric band and endoscopic sleevegastroplasty, or likely to undergo bariatric surgery during the study period
  5. Previous use of an intragastric gastric balloon
  6. Current use of an intragastric device, PlenityTM and digital weight loss solutions(e.g. Noom or Calibrate)
  7. History of any cancer other than non-melanoma skin cancer or papillary thyroid cancerwithin the last 5 years
  8. Benign or malignant gastrointestinal tumors
  9. History of chronic pancreatitis or acute pancreatitis within 12 months of enrollment
  10. History of, or current, small bowel obstruction
  11. History of severe GI motility disorder, such as severe gastroparesis
  12. History of any esophageal, gastric, or small bowel surgery
  13. History of, or current inflammatory bowel disease
  14. Any history of intraperitoneal adhesions
  15. Any history of open abdominal or gynecological surgery and/or radiation therapy to thebdomen, with the exception of cesarean sections performed at least 12 months prior toudy enrollment
  16. History of/or signs and symptoms of/or radiographic evidence of esophageal, gastric,duodenal disease including, but not limited to hiatal hernia ≥5cm, inflammatorydiseases, varices, severe gastroparesis, recent history of gastric or duodenal ulcers,ure/stenosis, achalasia, severe GERD requiring maximal medical therapy, or LAGrade B, C, or D esophagitis
  17. Diagnosis of autoimmune connective tissue disorder (e.g. lupus, erythematous,derma)
  18. Immunocompromised due to medications or medical disease or diagnosed with HIV
  19. History of genetic or endocrine causes of obesity not adequately controlled bydication, including hypothyroidism
  20. Type 1 diabetes or Type 2 diabetes with HgbA1c ≥ 7%, or treated with any anti-diabeticdications other than metformin
  21. Significant acute and/or chronic infections
  22. Severe coagulopathy defined as INR 1.5 or higher or platelet count <150, hepaticufficiency, or cirrhosis
  23. Unable or unwilling to discontinue use of aspirin and/or nonsteroidaly agents (NSAIDs) at least 7 days prior to Allurion Deployment anduing for 7 days after the Allurion Balloon is excreted
  24. Currently taking the following medications (within 30 days prior to enrollment) and/orhere is a need or anticipated need for these medications during the study: Excludeddications Systemic corticosteroids Anticoagulant therapy (e.g., warfarin,dabigatran) or anti-platelet therapy Immunosuppressive therapy (e.g., azathioprine,yclosporine) Narcotics, opiates, or benzodiazepines Insulin for treatment of diabetesAnti-seizure therapy (e.g., clonazepam, phenytoin) Anti-arrhythmics (e.g., amiodarone)
  25. Inability or unwillingness to take anti-emetics during the device residence
  26. Prescription or over-the- counter weight loss medication known to cause significantweight gain or weight loss within 90 days of study enrollment through study
  27. Uncontrolled or severe psychiatric disease other than mild depression with a patienthealth questionnaire score of 9 or below
  28. History of pulmonary embolism or deep venous thrombosis
  29. Has cardiac pacemaker or other electric implantable device
  30. Anemia defined as either:
    Hgb <11 g/dL for females, <12 g/dL for males
  31. Cessation of any nicotine product within 3 months of enrollment or plans to quit useduring the study
  32. Documented total body weight loss of ≥ 5% anytime 6 months preceding enrollment
  33. Residing in a location without access to study site medical resources
  34. History of or currently active eating disorders including night eating syndrome (NES),bulimia, or binge eating disorder
  35. Unwilling to refrain from any reconstructive and/or cosmetic surgery that may affectbody weight during the study such as mammoplasty and lipoplasty
  36. Current, or history of, illicit drug use (defined per state law) or excessive alcoholuse
  37. Enrolled in another investigational study that has not completed the required primarydpoint follow-up period (Note: Subjects involved in a long-term surveillance phaseher study are eligible for enrollment in this study).
  38. Current Use (within the last month) of any smoked or non-smoked marijuana productshat contain THC or unwilling to abstain from THC containing marijuana products duringhe trial.
  39. Any conditions that, in the opinion of each site investigator, may render the subjectunable to complete the study with a likely final outcome, or lead to difficulties forubject compliance with study requirements, or could confound study data.
  40. Subject is not of sufficient medical health as determined by the Investigator tohe study.
  41. Employees/family members of Allurion Technologies or any of its affiliates or
  42. Immediate employees/family members of the Investigator, sub- Investigators, or theirdical office or practice, or surgical, bariatric or hospital organizations at whichudy procedures may be performed
  43. An immediate family member (by marriage or blood relationship) of another subjectdy enrolled in the study
  44. Positive breath or stool test for H. Pylori
  45. History of covid-19 with any residual symptoms
  46. Known or suspected allergies to polyurethane
  47. Uncontrolled high blood pressure defined as ≥160/100 mmHg with or without medications
  48. Uncontrolled high cholesterol or triglycerides defined as LDL ≥190 mg/dL orglycerides ≥500 mg/dL
  49. Inability to swallow Allurion Practice Capsule

Updated on 01 Aug 2024. Study ID: TRL-1000-0007, GI-ALLURION-AUDACITY, 15169

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