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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
ReShape Medical, Inc.
ClinicalTrials.gov Identifier:
NCT01673698
First received: August 15, 2012
Last updated: November 2, 2015
Last verified: November 2015
Results First Received: August 25, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Obesity
Interventions: Device: ReShape Duo balloon
Other: Diet counseling
Other: Exercise counseling

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
ReShape Duo Balloon

ReShape Duo Balloon

ReShape Duo balloon

Diet counseling

Exercise counseling

Sham Comparator

Sham Comparator

Diet counseling

Exercise counseling


Participant Flow:   Overall Study
    ReShape Duo Balloon     Sham Comparator  
STARTED     187     139  
COMPLETED     136     126  
NOT COMPLETED     51     13  
Lost to Follow-up                 51                 13  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
ReShape Duo Balloon

ReShape Duo Balloon

ReShape Duo balloon

Diet counseling

Exercise counseling

Sham Comparator

Sham Comparator

Diet counseling

Exercise counseling

Total Total of all reporting groups

Baseline Measures
    ReShape Duo Balloon     Sham Comparator     Total  
Number of Participants  
[units: participants]
  187     139     326  
Age  
[units: years]
Mean (Standard Deviation)
  43.77  (9.51)     44.04  (10.17)     43.88  (9.78)  
Gender  
[units: participants]
     
Female     178     132     310  
Male     9     7     16  
Ethnicity (NIH/OMB)  
[units: participants]
     
Hispanic or Latino     15     8     23  
Not Hispanic or Latino     172     131     303  
Unknown or Not Reported     0     0     0  
Race (NIH/OMB)  
[units: participants]
     
American Indian or Alaska Native     0     1     1  
Asian     1     0     1  
Native Hawaiian or Other Pacific Islander     0     0     0  
Black or African American     25     16     41  
White     153     118     271  
More than one race     0     0     0  
Unknown or Not Reported     8     4     12  
BMI  
[units: kg/m^2]
Mean (Standard Deviation)
  35.32  (2.84)     35.43  (2.63)     35.37  (2.75)  



  Outcome Measures
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1.  Primary:   Comparison of Treatment % Excess Weight Loss (EWL) With Control %EWL at Week 24   [ Time Frame: Week 24 ]

2.  Primary:   Treatment Group Responder Rate Dichotomized at 25% EWL   [ Time Frame: 24 weeks ]

3.  Secondary:   Weight Loss Maintenance Six Months Following Device Removal   [ Time Frame: 48 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
There are no overall limitations and caveats.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Director of Clinical Operations
Organization: ReShape Medical
phone: 94429-6680
e-mail: lfong@reshapemedical.com



Responsible Party: ReShape Medical, Inc.
ClinicalTrials.gov Identifier: NCT01673698     History of Changes
Other Study ID Numbers: The REDUCE Pivotal Trial
Study First Received: August 15, 2012
Results First Received: August 25, 2015
Last Updated: November 2, 2015
Health Authority: United States: Food and Drug Administration