NCT05368259进行中（未招募）不适用
A Prospective, Open-Label, Multi-Center, Randomized, Pivotal Safety and Efficacy Study of the Allurion Gastric Balloon System + Moderate Intensity Lifestyle Modification Therapy Program vs. Moderate Intensity Lifestyle Modification Therapy Program for the Treatment of Adults With Obesity
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 1,000
- 试验地点
- 34
- 主要终点
- Responder Rate (RR) dichotomized at 5% TBWL at 48 week
研究概览
简要总结
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.
详细描述
Prospective, open-label, multi-center, randomized study comparing the AGBS + moderate intensity lifestyle modification therapy program vs. moderate intensity lifestyle modification therapy program for the treatment of adults with obesity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 22 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Responder Rate (RR) dichotomized at 5% TBWL at 48 week
时间窗: 48 weeks
Responder Rate (RR) dichotomized at 5% TBWL at 48 weeks is significantly greater than 50%
%TBWL is significantly greater than Control Group mean %TBWL at 48 weeks
时间窗: 48 weeks
%TBWL is significantly greater than Control Group mean %TBWL at 48 weeks, with a super superiority margin of 3.0%
次要结局
- Responder Rate (RR) dichotomized at both 5% and 10% TBWL at both 16 and 24 weeks(48 weeks)
研究者
研究点 (34)
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