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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01078194
Recruitment Status : Unknown
Verified January 2010 by Medical University of Vienna.
Recruitment status was:  Recruiting
First Posted : March 2, 2010
Last Update Posted : May 25, 2010
Sponsor:
Information provided by:
Medical University of Vienna

Brief Summary:
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 or disease Intervention/treatment
Morbid Obesity Device: Secondary Bypass Banding (adjustable A.M.I. Soft Gastric Band)

Study Type : Observational
Estimated Enrollment : 20 participants
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
Study Start Date : January 2010
Estimated Primary Completion Date : January 2013
Estimated Study Completion Date : January 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort Intervention/treatment
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



Primary Outcome Measures :
  1. Weight loss [ Time Frame: 2 years ]
    Excessive weight loss



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: March 2, 2010    Key Record Dates
Last Update Posted: May 25, 2010
Last Verified: January 2010

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

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