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