- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01024465
ReShape Intragastric Balloon for the Treatment of Obesity (ITALYIII)
September 10, 2015 updated by: ReShape Lifesciences
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).
Study Overview
Study Type
Interventional
Enrollment (Actual)
26
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Rovereto, Italy, 38068
- Casa di Cura Solatrix
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Vicenza, Italy, 36100
- Regional Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 60 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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
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ReShape Duo Balloon
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Total Weight Loss
Time Frame: baseline to 180 days
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Mean weight loss in kilograms compared with the baseline value through 6 months of study follow up.
|
baseline to 180 days
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Director: Mary Lou Mooney, ReShape Medical
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2009
Primary Completion (Actual)
May 1, 2010
Study Completion (Actual)
March 1, 2011
Study Registration Dates
First Submitted
November 25, 2009
First Submitted That Met QC Criteria
December 1, 2009
First Posted (Estimate)
December 2, 2009
Study Record Updates
Last Update Posted (Estimate)
September 29, 2015
Last Update Submitted That Met QC Criteria
September 10, 2015
Last Verified
September 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2009-1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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