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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 Description
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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).

Condition or disease Intervention/treatment Phase
Obesity Device: ReShape Duo Balloon Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: ReShape Intragastric Balloon for the Treatment of Obesity
Study Start Date : September 2009
Actual Primary Completion Date : May 2010
Actual Study Completion Date : March 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Weight Control

Arms and Interventions
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Arm Intervention/treatment
Experimental: ReShape Duo Balloon
Patients seeking weight loss with a starting BMI in the 30-40 range, received the ReShape Duo Balloon
 Device: ReShape Duo Balloon
ReShape Duo Balloon


Outcome Measures
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Primary Outcome Measures :
  1. 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.


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

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.
Contacts and Locations
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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): NCT01024465


Locations
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Italy
Casa di Cura Solatrix
Rovereto, Italy, 38068
Regional Hospital
Vicenza, Italy, 36100
Sponsors and Collaborators
ReShape Lifesciences
Regional Hospital. Viale Rodolfi 37. 36100 Vicenza. ITALY
Casa di Cura Solatrix. Via Bellini 11. 38068 Rovereto. ITALY
Investigators
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Study Director: Mary Lou Mooney ReShape Medical
More Information
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Responsible Party: ReShape Lifesciences
ClinicalTrials.gov Identifier: NCT01024465    
Other Study ID Numbers: 2009-1
First Posted: December 2, 2009    Key Record Dates
Results First Posted: September 11, 2015
Last Update Posted: September 29, 2015
Last Verified: September 2015
Keywords provided by ReShape Lifesciences:
obesity
intragastric balloon
Additional relevant MeSH terms:
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Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight