ReShape Intragastric Balloon for the Treatment of Obesity (ITALYIII)
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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
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Obesity | Device: ReShape Duo Balloon | Not Applicable |
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 |

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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Device: ReShape Duo Balloon
ReShape Duo Balloon |
- 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.

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

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
Italy | |
Casa di Cura Solatrix | |
Rovereto, Italy, 38068 | |
Regional Hospital | |
Vicenza, Italy, 36100 |
Study Director: | Mary Lou Mooney | ReShape Medical |
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 |
obesity intragastric balloon |
Obesity Overnutrition Nutrition Disorders Overweight Body Weight |