NCT01024465

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for not_applicable obesity

Timeline
Completed

Started Sep 2009

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2009

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 25, 2009

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 2, 2009

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2010

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed
4.5 years until next milestone

Results Posted

Study results publicly available

September 11, 2015

Completed
Last Updated

September 29, 2015

Status Verified

September 1, 2015

Enrollment Period

8 months

First QC Date

November 25, 2009

Results QC Date

August 13, 2015

Last Update Submit

September 10, 2015

Conditions

Obesity

Keywords

obesityintragastric balloon

Outcome Measures

Primary Outcomes (1)

  • Total Weight Loss

    Mean weight loss in kilograms compared with the baseline value through 6 months of study follow up.

    baseline to 180 days

Study Arms (1)

ReShape Duo Balloon

EXPERIMENTAL

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

Device: ReShape Duo Balloon

Interventions

ReShape Duo BalloonDEVICE

ReShape Duo Balloon

ReShape Duo Balloon

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Casa di Cura Solatrix

Rovereto, 38068, Italy

Location

Regional Hospital

Vicenza, 36100, Italy

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Limitations and Caveats

No limitations nor caveats apply.

Results Point of Contact

Title
Director of Clinical Operations
Organization
ReShape Medical
lfong@reshapemedical.com
949-429-6680

Study Officials

  • Mary Lou Mooney

    ReShape Medical

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 25, 2009

First Posted

December 2, 2009

Study Start

September 1, 2009

Primary Completion

May 1, 2010

Study Completion

March 1, 2011

Last Updated

September 29, 2015

Results First Posted

September 11, 2015

Record last verified: 2015-09

Locations

IT(2)