Clinical trial NCT01673698: A Prospective, Randomized Multicenter Study to Evaluate the Safety and Efficacy of the ReShape Duo™ Intragastric Balloon System in Obese Subjects
Official title: A Prospective, Randomized Multicenter Study to Evaluate the Safety and Efficacy of the ReShape Duo™ Intragastric Balloon System in Obese Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: obesity
weight loss
Lead sponsor: ReShape Lifesciences
Sponsor class: INDUSTRY
First posted: 2012-08-28
Enrollment: 326
Sex: ALL
Minimum age (years): 21
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


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™

Primary outcomes:
measure: Comparison of Treatment % Excess Weight Loss (EWL) With Control %EWL at Week 24
timeFrame: Week 24
measure: Treatment Group Responder Rate Dichotomized at 25% EWL
timeFrame: 24 weeks
Secondary outcomes:
measure: Weight Loss Maintenance Six Months Following Device Removal
timeFrame: 48 weeks
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Scottsdale Healthcare
state: Arizona
city: Dalton
country: United States
facility: Hamilton Medical Center
state: Georgia
city: Marquette
country: United States
facility: Marquette General Surgical Weight Loss Center
state: Michigan
city: Minneapolis
country: United States
facility: University of Minnesota/Department of Gastrointestinal Surgery
state: Minnesota
city: St. Louis
country: United States
facility: Washington University in St. Louis
state: Missouri
city: Simpsonville
country: United States
facility: Greenville Hospital System
state: South Carolina
city: Memphis
country: United States
facility: Midsouth Bariatrics
state: Tennessee
city: Houston
country: United States
facility: University of TX Health Science Center at Houston
state: Texas
Study officials:
affiliation: Lehmann Consulting
name: John Lehmann, MD, MPH
role: STUDY_DIRECTOR
affiliation: Hamilton Medical Center
name: Jaime Ponce, MD
role: PRINCIPAL_INVESTIGATOR
References: