ReShape Intragastric Balloon for the Treatment of Obesity

Obesity Clinical Trial

— ITALYIII  

Official title:

ReShape Intragastric Balloon for the Treatment of Obesity

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01024465
• Other study ID #: 2009-1
• Status: Completed
• Phase: N/A
• First received: November 25, 2009
• Last updated: September 10, 2015
• Start date: September 2009
• Est. completion date: March 2011

Study information

• Verified date: September 2015
• Source: ReShape Medical, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Servizio Sanitario Nazionale- Regione Veneto
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: March 2011
• Est. primary completion date: May 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 60 Years

Eligibility

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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Obesity

Intervention

Device:
• ReShape Duo Balloon
ReShape Duo Balloon

Locations

Country	Name	City	State
Italy	Casa di Cura Solatrix	Rovereto
Italy	Regional Hospital	Vicenza

Sponsors (3)

Lead Sponsor	Collaborator
ReShape Medical, Inc.	Casa di Cura Solatrix. Via Bellini 11. 38068 Rovereto. ITALY, Regional Hospital. Viale Rodolfi 37. 36100 Vicenza. ITALY

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total Weight Loss	Mean weight loss in kilograms compared with the baseline value through 6 months of study follow up.	baseline to 180 days	No