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ReShape Intragastric Balloon for the Treatment of Obesity (ITALYIII)

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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

Tracking Information
First Submitted Date  ICMJE November 25, 2009
First Posted Date  ICMJE December 2, 2009
Results First Submitted Date  ICMJE August 13, 2015
Results First Posted Date  ICMJE September 11, 2015
Last Update Posted Date September 29, 2015
Study Start Date  ICMJE September 2009
Actual Primary Completion Date May 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 10, 2015)
Total Weight Loss [ Time Frame: baseline to 180 days ]
Mean weight loss in kilograms compared with the baseline value through 6 months of study follow up.
Original Primary Outcome Measures  ICMJE
 (submitted: December 1, 2009)
Total Weight Loss [ Time Frame: 180 day ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE ReShape Intragastric Balloon for the Treatment of Obesity
Official Title  ICMJE ReShape Intragastric Balloon for the Treatment of Obesity
Brief Summary A prospective, non-randomized, open-label, multi-center study designed to implant up to twenty-six (26) CE-marked ReShape™ Balloons in twenty-six (26) patients with body mass index (BMI) 30-40 to assess the effectiveness of the device. The RIB devices will be used within their labeled indications and as per their instructions for use. Enrolled patients will be followed for seven months. The patient will be prescribed a controlled diet, exercise and counseling. One group of 26 patients will receive treatment as follows: Placement, inflate to 900 cc, remove at 180 days, follow-up 30 days post removal (endoscopic video capture of placement and removal required).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Obesity
Intervention  ICMJE Device: ReShape Duo Balloon
ReShape Duo Balloon
Study Arms  ICMJE Experimental: ReShape Duo Balloon
Patients seeking weight loss with a starting BMI in the 30-40 range, received the ReShape Duo Balloon
Intervention: Device: ReShape Duo Balloon
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 13, 2015)
26
Original Estimated Enrollment  ICMJE
 (submitted: December 1, 2009)
20
Actual Study Completion Date  ICMJE March 2011
Actual Primary Completion Date May 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • The patient is male or female between the ages of 20 and 60 years of age.
  • The patient presents with a Body Mass Index (BMI) 30-40 kg/m2.
  • The patient is geographically stable and willing to return to the implant center for follow-up visits.
  • The patient has been adequately informed of risks and requirements and consents to his/her participation in the post market clinical study.

Exclusion Criteria:

  • The patient presents with 20 years > Age > 60 years.
  • The patient has a progressive disease, which in the Investigator's experience produces an unacceptable increased risk to the patient, or results in a life expectancy of less than 12 months.
  • The patient is a pregnant or lactating female.
  • The patient presents with a 30 kg/m2 > BMI > 40 kg/m2.
  • The patient has had previous abdominal surgery.
  • The patient has digestive tract disorders such as active peptic ulcers, bleeding disorders, esophageal varices, Crohn's disease.
  • The patient presents with psychiatric disorders.
  • The patient is participating in concomitant research studies of investigational products that would interfere with this study.
  • The patient has inability to return for follow-up assessments.
  • The patient is an alcohol or drug abuser.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01024465
Other Study ID Numbers  ICMJE 2009-1
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party ReShape Lifesciences
Study Sponsor  ICMJE ReShape Lifesciences
Collaborators  ICMJE
  • Regional Hospital. Viale Rodolfi 37. 36100 Vicenza. ITALY
  • Casa di Cura Solatrix. Via Bellini 11. 38068 Rovereto. ITALY
Investigators  ICMJE
Study Director: Mary Lou Mooney ReShape Medical
PRS Account ReShape Lifesciences
Verification Date September 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP