A Prospective, Randomized Multicenter Study to Evaluate the Safety and Efficacy of the ReShape Duo™ Intragastric Balloon System in Obese Subjects
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
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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.
Condition or disease
Device: ReShape Duo balloonOther: Diet counselingOther: Exercise counseling
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Layout table for eligibility information
Ages Eligible for Study:
21 Years to 60 Years (Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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.
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:
Clinically significant hiatal hernia (> 3 cm)
Patulous pyloric channel
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™