NCT03261453已完成不适用
A Randomized, Multi-Center, Phased, Pivotal Safety and Efficacy Study Comparing the Elipse™ Gastric Balloon System vs. Sham for the Treatment of Obese Adults
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 400
- 试验地点
- 23
- 主要终点
- Primary Safety Endpoint: Incidence of overall procedure or device related Serious Adverse Events
研究概览
简要总结
The primary objective of this study is to demonstrate the safety and efficacy of the Elipse Gastric Balloon System for the treatment of obese adults.
详细描述
This is a prospective, double-blinded, randomized, two-phase study to be conducted in a planned 400 obese individuals drawn from up to 15 sites. The treatment duration of the study is 48 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
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
- 否
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.
- •Confirmed unsuccessful attempts at more conservative weight reduction alternatives, such as supervised diet, exercise and behavior modification programs attempted within the 24 months preceding enrollment.
排除标准
- •Symptomatic congestive heart failure, cardiac arrhythmia or unstable coronary artery disease
- •Pre-existing respiratory disease such as chronic obstructive pulmonary disease (COPD), pneumonia or cancer
- •Previous bariatric or gastric surgery or likely to undergo during study
- •Use of an intragastric device prior to this study
- •Chronic pancreatitis or acute pancreatitis within 12 months of enrollment
- •History of or current small bowel obstructions
- •History of abdominal and/or pelvic surgery EXCLUDING only ONE of the following surgeries that was performed at least 12 months prior to study enrollment: cesarean section, diagnostic laparoscopy, laparoscopic appendectomy, laparoscopic cholecystectomy. (For example: if a patient has had 2 cesarean sections, or one cesarean section and a laparoscopic appendectomy, she would be excluded. If a patient had one cesarean section, she may be included)
- •Diagnosis of autoimmune connective tissue disorder (e.g. lupus, erythematous, scleroderma) or immunocompromised
- •History of genetic or endocrine causes of obesity not adequately controlled by medication
- •History of/or signs and/or symptoms of/or radiographic evidence of esophageal, gastric, or duodenal disease including but not limited to hiatal hernias greater than or equal to 2 centimeter (cm), paraesophageal hernias, inflammatory diseases, cancer, varices, diverticula, gastroparesis, ulcers, stricture/stenosis, achalasia and esophagitis
- •Insulin-dependent diabetes (either Type 1 or Type 2)
- •Significant acute and/or chronic infections of any kind
- •Severe coagulopathy, hepatic insufficiency or cirrhosis
- •Unable or unwilling to discontinue use of aspirin and/or non-steroidal anti-inflammatory agents (NSAIDs) at least 14 days prior to Elipse Deployment and continuing for 14 days after Elipse excretion
- •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. warafin, dabigatran) or anti-platelet therapy) Immunosuppressive therapy (e.g. azathioprine, cyclosporine) Prescription or over the counter weight loss medication(s) Medications known to cause significant weight gain or weight loss Narcotics, opiates or benzodiazepines Insulin for treatment of diabetes Anti-seizure therapy (e.g. clonazepam, phenytoin) Anti-arrhythmics (e.g. amidarone)
- •History of pulmonary embolism
- •Has cardiac pacemaker or other electric implantable device
- •Anemia defined as either:
- •Hgb < 11 for females, <12 for males
- •Abnormal red cell indices and iron deficiency
- •Smoking cessation within 3 months of enrollment or plans to quit smoking during the study
- •Documented total body weight loss of ≥ 5% anytime 6 months preceding enrollment
- •Residing in a location without ready access to study site medical resources
- •Inability to walk 200 yards without assistance
- •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 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).
- •Any conditions that, in the opinion of the investigator, may render the subject unable to complete the study with a likely fatal outcome, or lead to difficulties for subject compliance with study requirements, or could confound study data.
- •Patient 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 test for H. Pylori
- •History of or current inflammatory bowel disease (e.g. Crohn's disease, Ulcerative Colitis)
结局指标
主要结局
Primary Safety Endpoint: Incidence of overall procedure or device related Serious Adverse Events
时间窗: 24 weeks
The primary safety endpoint of this clinical investigation is the overall incidence of procedure- or device-related Serious Adverse Events through 24 weeks.
Co-Primary Effectiveness Endpoint 2: Percent of Total Body Weight Loss (TBWL) Comparison Between Treatment and Control group
时间窗: 16 weeks
An inferential test of whether the Treatment Group mean %TBWL is significantly greater than Control Group mean % TBWL at 16 weeks
Co-Primary Effectiveness Endpoint: Total Body Weight Loss (TBWL) Comparison Between Treatment and Control Group at 16 weeks
时间窗: 16 weeks
An inferential test of whether the Treatment Group Responder Rate (RR) dichotomized at 5% TBWL at 16 weeks is significantly greater than 35%.
次要结局
未报告次要终点
研究者
研究点 (23)
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