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

NCT01673698 | Completed Results DMC

• 1 other identifier: The REDUCE Pivotal Trial
• Study Type: interventional
• Target: 326
• Locations: 1 country
• Sites: 8

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.

Conditions

Obesity

Keywords

obesity; weight loss

Outcome Measures

Primary Outcomes (2)

• Comparison of Treatment % Excess Weight Loss (EWL) With Control %EWL at 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%.

  Week 24

• Treatment Group Responder Rate Dichotomized at 25% EWL

  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%.

  24 weeks

Secondary Outcomes (1)

• Weight Loss Maintenance Six Months Following Device Removal

  48 weeks

Study Arms (2)

ReShape Duo Balloon

ACTIVE COMPARATOR

ReShape Duo Balloon

Device: ReShape Duo balloon; Other: Diet counseling; Other: Exercise counseling

Sham Comparator

SHAM COMPARATOR

Sham Comparator

Other: Diet counseling; Other: Exercise counseling

Interventions

ReShape Duo balloon DEVICE

ReShape Duo Balloon

Diet counseling OTHER

ReShape Duo Balloon; Sham Comparator

Exercise counseling OTHER

ReShape Duo Balloon; Sham Comparator

Eligibility Criteria

• Age: 21 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• ReShape Lifesciences: lead

Study Sites (8)

Scottsdale Healthcare

Scottsdale, Arizona, 85258, United States

Location

Hamilton Medical Center

Dalton, Georgia, 30720, United States

Location

Marquette General Surgical Weight Loss Center

Marquette, Michigan, 49855, United States

Location

University of Minnesota/Department of Gastrointestinal Surgery

Minneapolis, Minnesota, 55455, United States

Location

Washington University in St. Louis

St Louis, Missouri, 63110, United States

Location

Greenville Hospital System

Simpsonville, South Carolina, 29680, United States

Location

Midsouth Bariatrics

Memphis, Tennessee, 38120, United States

Location

University of TX Health Science Center at Houston

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Obesity; Weight Loss

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes

Limitations and Caveats

There are no overall limitations and caveats.

Results Point of Contact

• Title: Director of Clinical Operations
• Organization: ReShape Medical

lfong@reshapemedical.com

94429-6680

Study Officials

• John Lehmann, MD, MPH

  Lehmann Consulting

  STUDY DIRECTOR

• Jaime Ponce, MD

  Hamilton Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 15, 2012
• First Posted: August 28, 2012
• Study Start: August 1, 2012
• Primary Completion: April 1, 2014
• Study Completion: September 1, 2014
• Last Updated: December 7, 2015
• Results First Posted: December 7, 2015

Record last verified: 2015-11

Locations

US (8)