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The Safety and Efficacy of the ReShape Intragastric Balloon in Obese Subjects

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01061385
First Posted: February 3, 2010
Last Update Posted: May 13, 2016
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. Read our disclaimer for details.
Information provided by (Responsible Party):
ReShape Medical, Inc.
  Purpose
The study evaluated the safety and efficacy of the ReShape Intragastric Balloon as an adjunct to diet and exercise in obese patients compared with diet and exercise alone. The study device is designed to occupy space within the stomach and induce satiety. After approval from the institutional review board, patients provided written consent and were randomized to the treatment group (with endoscopic placement of study device) or the control group (no placement of study device) on an unblinded basis. Both groups received similar diet and exercise counseling. After 24 weeks, the device was removed. Patient weight, adverse events, and quality of life data were evaluated throughout the 48 week study duration.

Condition Intervention
Obesity Device: ReShape Intragastric Balloon Other: Control Arm

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: IDE G090121 A Prospective, Randomized Multicenter Study to Evaluate the Safety and Efficacy of the ReShape Intragastric Balloon (RIBTM) in Obese Subjects

Resource links provided by NLM:


Further study details as provided by ReShape Medical, Inc.:

Primary Outcome Measures:
  • %Excess Weight Loss [ Time Frame: 36 Weeks ]
    the difference between the %EWL between treatment and control groups must be clinically significant


Secondary Outcome Measures:
  • Percentage of Subjects With >=25% Excess Weight Loss (EWL) [ Time Frame: 12 months ]
    a between-group comparison of percentage of treatment subjects achieving >=25% EWL (using the Metropolitan Life Tables (ML) method) compared to the percentage of control group subjects achieving >= 25%EWL at 12 months


Enrollment: 30
Study Start Date: February 2010
Study Completion Date: July 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ReShape Intragastric Balloon
Patients receiving the ReShape Intragastric Balloon
Device: ReShape Intragastric Balloon
Placement of ReShape Medical Intragastric Balloon for twenty four weeks
Control Arm
Weight loss using behavior modification (diet and exercise counseling) alone
Other: Control Arm
Behavioral Modification (Diet and exercise counseling) alone

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Subjects aged ≥ 20 years and ≤ 60 years;
  2. At screening, body mass index (BMI) ≥ 30 Kg/m^2 and ≤ 40 Kg/m^2;
  3. Have a history of obesity (BMI ≥ 30 kg/m^2) for at least 6 months and have failed other weight-reduction alternatives, such as supervised diet, exercise and behavioral modification programs;
  4. Subject is willing to commit to a long-term low calorie (1000-1500 calories/day) supervised diet;
  5. Subject has reasonable weight loss expectations (accept a goal of losing up to 15% of body weight after 24 weeks);
  6. At screening, total Beck Depression Inventory (BDI) score < 12 points, and BDI affective subscale score < 7 points.
  7. Subject is able to follow requirements outlined in the protocol, including complying with the visit schedule, and willing to undergo protocol-specific procedures, e.g., endoscopy, local sedation, general anesthesia, electrocardiography (ECG), and/or clinical laboratory testing;
  8. Subject is willing to take prescribed proton pump inhibitors (PPIs);
  9. Subject is able to provide written informed consent;
  10. If female of child-bearing potential, the subject is willing to use contraception (e.g., birth control pills, condoms, abstinence) and avoid pregnancy during the study.

Exclusion Criteria:

  1. Participating in an organized weight loss program (e.g., Weight Watchers);
  2. Parkinson's disease;
  3. Chronic narcotic use;
  4. Clinically relevant abdominal adhesions (e.g., history of bowel obstruction);
  5. History or symptoms of gastrointestinal (GI) surgery (excluding uncomplicated appendectomy and cholecystectomy), obstruction, and/or adhesive peritonitis;
  6. History or symptoms of clinically significant esophageal or GI motility disorders;
  7. A hormonal or genetic cause for subject's obesity;
  8. A history of myocardial infarction in the previous 6 months, current New York Heart Association (NYHA) Functional Class III or IV (heart failure) or cardiac arrhythmia (e.g., atrial fibrillation);
  9. History or symptoms of varices, bowel obstruction, congenital or acquired GI anomalies (e.g., atresias, stenosis, stricture, and/or diverticula), severe renal, hepatic, and/or pulmonary disease;
  10. History or symptoms of inflammatory bowel disease, such as Crohn's disease;
  11. History or symptoms of uncontrolled or unstable thyroid disease;
  12. Subjects with a positive breath test for Helicobacter pylori at screening;
  13. History or symptoms in the past 12 months of significant irritable bowel disease, peritonitis, active esophagitis, gastric or duodenal ulceration, or GI bleeding;
  14. History of esophageal and/or stomach cancer.
  15. Type I diabetes;
  16. Placement of previous intragastric balloon or similar device with associated adverse; or any endogastric procedure within the last 6 months;
  17. Ongoing treatment with anticoagulants, steroids, aspirin (> 81 mg/day), non-steroidal anti-inflammatory drugs (NSAIDS), or other medications known to be gastric irritants or to reduce GI motility, and unwillingness to discontinue the use of these concomitant medications;
  18. Concomitant use of prescription, non-prescription, or over-the-counter weight loss medications or supplements at any time during the study;
  19. Evidence of untreated psychiatric or eating disorders, such as major depression, schizophrenia, substance abuse, binge eating disorder, or bulimia;
  20. Pregnancy, breast feeding, or intention of becoming pregnant during the study (if female of childbearing potential);
  21. Known allergy to silicone;
  22. A history of anemia
  23. Participation in another investigational trial within 1 month of screening or planned enrollment during the study period.
  24. Presence of peptic ulcerations, hiatal hernia (> 2 cm), patulous pyloric channel, erosive esophagitis, varices, angiectasia, Barrett's esophagus or other findings deemed exclusionary in the opinion of the investigator.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01061385


Sponsors and Collaborators
ReShape Medical, Inc.
Investigators
Study Director: Mary Lou Mooney ReShape Medical
  More Information

Responsible Party: ReShape Medical, Inc.
ClinicalTrials.gov Identifier: NCT01061385     History of Changes
Other Study ID Numbers: REDUCE-IDE
First Submitted: February 1, 2010
First Posted: February 3, 2010
Results First Submitted: August 7, 2015
Results First Posted: December 7, 2015
Last Update Posted: May 13, 2016
Last Verified: April 2016