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ReShape Intragastric Balloon for the Treatment of Obesity (ITALYIII)

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.
 
ClinicalTrials.gov Identifier: NCT01024465
Recruitment Status : Completed
First Posted : December 2, 2009
Results First Posted : September 11, 2015
Last Update Posted : September 29, 2015
Sponsor:
Collaborators:
Regional Hospital. Viale Rodolfi 37. 36100 Vicenza. ITALY
Casa di Cura Solatrix. Via Bellini 11. 38068 Rovereto. ITALY
Information provided by (Responsible Party):
ReShape Lifesciences

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Obesity
Intervention Device: ReShape Duo Balloon
Enrollment 26
Recruitment Details  
Pre-assignment Details  
Arm/Group Title ReShape Duo Balloon
Hide Arm/Group Description

Patients seeking weight loss with a starting BMI in the 30-40 range, received the ReShape Duo Balloon

ReShape Duo Balloon: ReShape Duo Balloon

Period Title: Overall Study
Started 26
Completed 23
Not Completed 3
Reason Not Completed
Adverse Event             2
Physician Decision             1
Arm/Group Title ReShape Duo Balloon
Hide Arm/Group Description

Patients seeking weight loss with a starting BMI in the 30-40 range, received the ReShape Duo Balloon

ReShape Duo Balloon: ReShape Duo Balloon

Overall Number of Baseline Participants 26
Hide Baseline Analysis Population Description
Participants were enrolled who met the study's inclusion/exclusion criteria.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 26 participants
39.7  (11.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 26 participants
Female
22
  84.6%
Male
4
  15.4%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 26 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
26
 100.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
1.Primary Outcome
Title Total Weight Loss
Hide Description Mean weight loss in kilograms compared with the baseline value through 6 months of study follow up.
Time Frame baseline to 180 days
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects with a weight recorded at 6 months
Arm/Group Title ReShape Duo Balloon
Hide Arm/Group Description:

Patients seeking weight loss with a starting BMI in the 30-40 range, received the ReShape Duo Balloon

ReShape Duo Balloon: ReShape Duo Balloon

Overall Number of Participants Analyzed 22
Mean (Standard Deviation)
Unit of Measure: kg
-9.4  (6.3)
Time Frame 180 days
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title ReShape Duo Balloon
Hide Arm/Group Description

Patients seeking weight loss with a starting BMI in the 30-40 range, received the ReShape Duo Balloon

ReShape Duo Balloon: ReShape Duo Balloon

All-Cause Mortality
ReShape Duo Balloon
Affected / at Risk (%)
Total   --/-- 
Hide Serious Adverse Events
ReShape Duo Balloon
Affected / at Risk (%)
Total   0/26 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
ReShape Duo Balloon
Affected / at Risk (%)
Total   16/26 (61.54%) 
Gastrointestinal disorders   
nausea/vomiting after discharge  1  4/26 (15.38%) 
gastric bloating  1  4/26 (15.38%) 
epigastric pain  1  3/26 (11.54%) 
GERD  1  3/26 (11.54%) 
ulcer at removal  1  3/26 (11.54%) 
diarrhea  1  2/26 (7.69%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, verbatim
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.
Upon study conclusion, the PI has the right to use the study data for educational purposes, scientific conferences and publications. The sponsor will have a period of 15 days (for abstracts) and 30 days (for scientific publications) to review the proposal for disclosure / publication for the sole purpose of protecting any confidential information. If such disclosure contains Confidential Information, the PI agrees to remove such Confidential Information.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Director of Clinical Operations
Organization: ReShape Medical
Phone: 949-429-6680
EMail: lfong@reshapemedical.com
Layout table for additonal information
Responsible Party: ReShape Lifesciences
ClinicalTrials.gov Identifier: NCT01024465    
Other Study ID Numbers: 2009-1
First Submitted: November 25, 2009
First Posted: December 2, 2009
Results First Submitted: August 13, 2015
Results First Posted: September 11, 2015
Last Update Posted: September 29, 2015