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ReShape Intragastric Balloon for the Treatment of Obesity (ITALY III)

This study has been completed.
Sponsor:
Collaborators:
Regional Hospital. Viale Rodolfi 37. 36100 Vicenza. ITALY
Casa di Cura Solatrix. Via Bellini 11. 38068 Rovereto. ITALY
Information provided by (Responsible Party):
ReShape Medical, Inc.
ClinicalTrials.gov Identifier:
NCT01024465
First received: November 25, 2009
Last updated: June 5, 2012
Last verified: June 2012
History of Changes
  Purpose

A prospective, non-randomized, open-label, multi-center study designed to implant up to twenty (20) CE-marked ReShape™ Balloons in twenty (20) 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 20 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).


Condition Intervention
Obesity
 Device: Intragastric Balloon

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: ReShape Intragastric Balloon for the Treatment of Obesity

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by ReShape Medical, Inc.:

Primary Outcome Measures:
  • Total Weight Loss [ Time Frame: 180 day ] [ Designated as safety issue: No ]

Enrollment: 23
Study Start Date: September 2009
Study Completion Date: March 2011
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BMI 30-40
Patients seeking weight loss with a starting BMI in the 30-40 range.
 Device: Intragastric Balloon
Endoscopic insertion of an Intragastric Balloon

  Eligibility

Ages Eligible for Study:   20 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01024465

Locations
Italy
Casa di Cura Solatrix
Rovereto, Italy, 38068
Regional Hospital
Vicenza, Italy, 36100
Sponsors and Collaborators
ReShape Medical, Inc.
Regional Hospital. Viale Rodolfi 37. 36100 Vicenza. ITALY
Casa di Cura Solatrix. Via Bellini 11. 38068 Rovereto. ITALY
Investigators
Study Director: Mary Lou Mooney ReShape Medical
  More Information

No publications provided

Responsible Party: ReShape Medical, Inc.
ClinicalTrials.gov Identifier: NCT01024465     History of Changes
Other Study ID Numbers: 2009-1
Study First Received: November 25, 2009
Last Updated: June 5, 2012
Health Authority: Italy: Servizio Sanitario Nazionale- Regione Veneto

Keywords provided by ReShape Medical, Inc.:
obesity
intragastric balloon

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
 Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on May 19, 2013