A Prospective, Randomized Multicenter Study to Evaluate the Safety and Efficacy of the ReShape Duo™ Intragastric Balloon System in Obese Subjects

Launched by RESHAPE LIFESCIENCES · Aug 23, 2012

Keywords

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Gender

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Eligibility criteria

• Inclusion criteria:
• • 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:
• • 1. A medically or commercially supervised weight loss program involving regular counseling regarding both diet and exercise.
• • 2. 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
• • 1. be postmenopausal for at least 1 year OR
• • 2. be surgically sterile, OR
• • 3. 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.
• Exclusion criteria:
• • 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:
• • 1. Hemoglobin (Hgb) value for females of \< 11.0 g/dl, for males \< 12.0 g/dl
• • 2. 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:
• • 1. Inability or unwillingness to sign the patient informed consent document.
• • 2. Inability to participate in all necessary study activities due to physical or mental limitations.
• • 3. 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
• • Varices
• • 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™