NCT01673698已完成不适用
A Prospective, Randomized Multicenter Study to Evaluate the Safety and Efficacy of the ReShape Duo™ Intragastric Balloon System in Obese Subjects
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 326
- 试验地点
- 8
- 主要终点
- Comparison of Treatment % Excess Weight Loss (EWL) With Control %EWL at Week 24
研究概览
简要总结
The REDUCE Pivotal Trial is a pivotal clinical study designed to develop valid scientific evidence regarding the safety and effectiveness of the ReShape Duo® as an adjunct to diet and exercise in the treatment of obese subjects with one or more obesity-related comorbid conditions.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients 21 to 60 years of age
- •Body Mass Index (BMI) ≥ 30 kg/m^2 and ≤ 40 kg/m^2
- •At least 5 years of obesity (with BMI ≥ 30)
- •Stable weight, defined as a subject who has not gained or lost ≥ 5% of body weight in the 3 months preceding the screening assessment
- •Failure to lose weight, within the 36 months preceding the screening date, after participation in either of the following:
- •A medically or commercially supervised weight loss program involving regular counseling regarding both diet and exercise.
- •Use of a United States Food and Drug Administration (FDA)-approved diet drug
- •The presence of one or more obesity-related comorbid conditions
- •Willing and able to provide Informed Consent
- •Willing and able to comply with study procedures and visit schedules as specified by the protocol
- •If female, the patient must
- •be postmenopausal for at least 1 year OR
- •be surgically sterile, OR
- •if of child bearing potential, must be practicing birth control, be willing to avoid pregnancy for the year of study participation, have a negative serum pregnancy test at screening, and a negative urine pregnancy test at baseline
- •Residing within a reasonable distance from the Investigator's treating office and able and willing to travel to the Investigator's office to complete all routine follow-up visits.
排除标准
- •History of and/or ongoing clinically significant conditions or disorders of the gastrointestinal (GI) tract
- •Clinically significant and uncontrolled/unstable hepatic, reproductive, gastrointestinal, renal, hematologic, pulmonary, neurologic, psychiatric, respiratory, endocrine, or cardiovascular system diseases
- •Significant acute and/or chronic infections of any kind.
- •Severe coagulopathy, hepatic insufficiency or cirrhosis
- •Uncontrolled or severe asthma, or any asthma requiring or likely to require inhaled steroid therapy during the anticipated duration of trial participation
- •Severe obstructive sleep apnea
- •Incompletely controlled hypothyroidism or hyperthyroidism
- •Severe systemic disease [consistent with an ASA (American Society of Anesthesia) Physical Status Classification Score of 3 or greater]
- •Eating disorders, especially binge eating
- •Inability to walk 200 yards without assistance
- •Known allergies to any of the device materials or accessories, i.e. silicone, methylene blue, corn starch
- •Active drug or alcohol addiction within 12 months of enrollment
- •Insulin-dependent diabetes (either Type 1 or Type 2) or a significant likelihood of requiring insulin treatment in the following 12 months
- •Depressive disorder with total Beck Depression Inventory (BDI) score > 16 points, and/or BDI affective subscale score > 7 points at screening
- •Ongoing treatment, or anticipated need for such treatment, with anticoagulants, known gastric irritants such as aspirin (ASA) or non-steroidal anti-inflammatory drugs (NSAIDs) or agents that can promote gastrointestinal bleeding, within 1 month prior to enrollment, or unwillingness to forego these medications during the study period
- •Participation within 60 days of screening date in previous or ongoing clinical trial or current usage of an investigational drug or device
- •Any use of an intragastric device prior to this study.
- •Genetically caused obesity, such as Prader-Willi syndrome
- •Any prior bariatric surgery or likely to undergo bariatric surgery during study follow-up period
- •Concomitant use of, or unwillingness to avoid any use of, weight loss medications, weight loss supplements, weight loss herbal preparations and/or participation in any non-study-related organized weight loss program (commercial or medical) at any time during the study, including online or smart phone applications to track or modify food intake, exercise regimens or weight
- •Chronic opiate use (> 3 months continuous use) or likely need for opiate use during study participation
- •Contraindication or allergy to, or unwillingness to use, proton pump inhibitor medication throughout study follow-up duration-Pregnancy, breast feeding, or intention of becoming pregnant during the study
- •Any screening laboratory values outside of the normal range deemed clinically significant by the Investigator
- •Anemia defined as either:
- •Hemoglobin (Hgb) value for females of < 11.0 g/dl, for males < 12.0 g/dl
- •Abnormal red cell indices and iron deficiency
- •Smoking cessation within 3 months of study entry or plans to quit smoking during the study
- •Major surgery, open biopsy or significant traumatic injury within 3 months prior to enrollment.
- •History of significant adverse experience with sedation or anesthesia
- •Serious or uncontrolled psychiatric illness or disorder that could compromise patient understanding of or compliance with study procedures
- •Any condition that, in the opinion of the Investigator, would compromise the well-being of the patient or the study or prevent the patient from meeting or performing study requirements, including:
- •Inability or unwillingness to sign the patient informed consent document.
- •Inability to participate in all necessary study activities due to physical or mental limitations.
- •Inability or unwillingness to return for all required follow-up visits.
- •Employees/family members of ReShape Medical® or any of its affiliates or contractors
- •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 REDUCE Pivotal Trial
- •Endoscopic exclusion criteria:
- •Peptic ulcerations
- •Clinically significant hiatal hernia (> 3 cm)
- •Patulous pyloric channel
- •Erosive esophagitis
- •Angiectasias
- •Barrett's esophagus
- •Esophageal stricture
- •Gastric mass
- •Any other subject characteristic that would prevent the successful insertion of a ReShape Duo™ or that in the opinion of the Investigator preclude safe use of the ReShape Duo™
研究组 & 干预措施
ReShape Duo Balloon
Active Comparator
ReShape Duo Balloon
干预措施: ReShape Duo balloon (Device)
ReShape Duo Balloon
Active Comparator
ReShape Duo Balloon
干预措施: Diet counseling (Other)
ReShape Duo Balloon
Active Comparator
ReShape Duo Balloon
干预措施: Exercise counseling (Other)
Sham Comparator
Sham Comparator
Sham Comparator
干预措施: Exercise counseling (Other)
Sham Comparator
Sham Comparator
Sham Comparator
干预措施: Diet counseling (Other)
结局指标
主要结局
Comparison of Treatment % Excess Weight Loss (EWL) With Control %EWL at Week 24
时间窗: Week 24
An inferential test of whether the difference in the mean %EWL between the Treatment and Control groups at 24 weeks was significantly greater than a superiority margin 7.5%.
Treatment Group Responder Rate Dichotomized at 25% EWL
时间窗: 24 weeks
An inferential test of whether the percentage of participants in the Treatment Group with a weight loss of \>25% EWL at 24 weeks was significantly greater than 35%.
次要结局
- Weight Loss Maintenance Six Months Following Device Removal(48 weeks)
研究者
研究点 (8)
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