ReShape Intragastric Balloon for the Treatment of Obesity

Not Applicable

Completed

• Conditions: Obesity
• Interventions: Device: ReShape Duo Balloon

• Registration Number: NCT01024465
• Lead Sponsor: ReShape Lifesciences

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 available

Study Timeline

• Study Start: 2009-09
• Study First Submitted: 2009-11-25
• Study First Submitted QC: 2009-12-01
• Study First Posted: 2009-12-02
• Primary Completion: 2010-05
• Study Completion: 2011-03
• Results First Submitted: 2015-08-13
• Results First Submitted QC: 2015-08-13
• Status Verified: 2015-09
• Last Update Submitted: 2015-09-10
• Results First Posted: 2015-09-11
• Last Update Posted: 2015-09-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Total Weight Loss	baseline to 180 days	Mean weight loss in kilograms compared with the baseline value through 6 months of study follow up.

Trial Locations

Locations (2)

Casa di Cura Solatrix; 🇮🇹 Rovereto, Italy

Regional Hospital; 🇮🇹 Vicenza, Italy