ReShape Intragastric Balloon for the Treatment of Obesity

NCT ID: NCT01024465

Last Updated: 2015-09-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-09-30
• Study Completion Date: 2011-03-31

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).

Conditions

Obesity

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ReShape Duo Balloon

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

Group Type: EXPERIMENTAL

ReShape Duo Balloon

Intervention Type: DEVICE

ReShape Duo Balloon

Interventions

ReShape Duo Balloon

ReShape Duo Balloon

Intervention Type: DEVICE

Eligibility 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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Regional Hospital. Viale Rodolfi 37. 36100 Vicenza. ITALY

UNKNOWN

Sponsor Role: collaborator

Casa di Cura Solatrix. Via Bellini 11. 38068 Rovereto. ITALY

UNKNOWN

Sponsor Role: collaborator

ReShape Lifesciences

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mary Lou Mooney

Role: STUDY_DIRECTOR

ReShape Medical

Locations

Casa di Cura Solatrix

Rovereto, , Italy

Regional Hospital

Vicenza, , Italy

Countries

Italy

Other Identifiers

2009-1

Identifier Type: -

Identifier Source: org_study_id