Text Size

Secondary Bypass Banding for Weight Regain or Weight Loss Failure After Lap. Gastric Bypass

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2010 by Medical University of Vienna.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT01078194
First received: March 1, 2010
Last updated: May 24, 2010
Last verified: January 2010
History of Changes
  Purpose

This is an observational study on the efficacy of the secondary placement of the A.M.I Soft Gastric Band in weight regain or weight loss failure after lap. gastric bypass.


Condition Intervention
Morbid Obesity
 Device: Secondary Bypass Banding (adjustable A.M.I. Soft Gastric Band)

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Observational Study on the Secondary Placement of the A.M.I. Soft Gastric Band in Weight Regain or Weight Loss Failure After Lap. Gastric Bypass

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Medical University of Vienna:

Primary Outcome Measures:
  • Weight loss [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Excessive weight loss


Estimated Enrollment: 20
Study Start Date: January 2010
Estimated Study Completion Date: January 2013
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Weight regain / weight loss failure
Weight regain of more than 10 kg from or weight loss of less than 50% EWL 18 months after lap. gastric bypass
 Device: Secondary Bypass Banding (adjustable A.M.I. Soft Gastric Band)
Secondary Placement of the A.M.I. Soft Gastric Band for laparoscopic bypass banding
Other Name: A.M.I. Soft Gastric Band

  Eligibility

Ages Eligible for Study:   20 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Weight regain of more than 10 kg from nadir or weight loss failure defined as excessive weight loss of less than 50% 18 months after laparoscopic gastric bypass

Criteria

Inclusion Criteria:

  • Weight regain of more than 10 kg from nadir
  • Excessive weight loss of less than 50% at 18 months after laparoscopic gastric bypass

Exclusion Criteria:

  • Formerly leak at the gastrojejunostomy
  • Formerly open abdominal surgery
  • Anastomotic ulcer
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01078194

Contacts
Contact: Gerhard Prager, M.D. +43-1-40400 ext 5621 gerhard.prager@meduniwien.ac.at
Contact: Felix B Langer, M.D. +43-1-40400 ext 5621 felix.langer@meduniwien.ac.at

Locations
Austria
Medical University of Vienna, Department of Surgery Recruiting
Vienna, Austria, 1090
Contact: Gerhard Prager, M-D-     +43-1-40400 ext 5621     gerhard.prager@meduniwien.ac.at    
Contact: Felix B Langer, M.D.     +43-1-40400 ext 5621     felix.langer@meduniwien.ac.at    
Sponsors and Collaborators
Medical University of Vienna
Investigators
Principal Investigator: Gerhard Prager, M.D. Medical University of Vienna, Department of Surgery
  More Information

No publications provided

Responsible Party: Gerhard Prager / M.D., Medical University of Vienna / Department of Surgery
ClinicalTrials.gov Identifier: NCT01078194     History of Changes
Other Study ID Numbers: MUW ADIP STUDY 16
Study First Received: March 1, 2010
Last Updated: May 24, 2010
Health Authority: Austria: Ethikkommission

Keywords provided by Medical University of Vienna:
Weight regain
Weight loss failure
Gastric bypass

Additional relevant MeSH terms:
Obesity
Obesity, Morbid
Weight Loss
Overnutrition
Nutrition Disorders
 Overweight
Body Weight
Signs and Symptoms
Body Weight Changes

ClinicalTrials.gov processed this record on May 16, 2013