MedTrace Logo

Efficacy of Preoperative Intra Gastric Balloon in Morbidly Obese Patients Selected for Gastric By-pass

NCT00504036 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 314

Last updated 2011-11-01

No results posted yet for this study

Summary

To demonstrate, during a prospective randomized medico-economic study, in morbidly obese patients (BMI \> 45 kg/m²) selected for a laparoscopic gastric by-pass that, in comparison to usual care, a temporary intra-gastric balloon (6 months) decreases medical costs and peri-operative morbidity.

Conditions

  • Morbid Obesity

Interventions

DEVICE

inflatable intra-gastric balloon

inflatable intra-gastric balloon

Sponsors & Collaborators

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Benoit Coffin, PU-PH · Assistance Publique - Hôpitaux de Paris

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-10-31
Primary Completion
2011-07-31
Completion
2011-07-31

Countries

  • France

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00504036 on ClinicalTrials.gov