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

May 24, 2010 updated by: Medical University of Vienna

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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 Names:
  • A.M.I. Soft Gastric Band

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Weight loss
Time Frame: 2 years
Excessive weight loss
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Vienna

Investigators

  • Principal Investigator: Gerhard Prager, M.D., Medical University of Vienna, Department of Surgery

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (Anticipated)

January 1, 2013

Study Completion (Anticipated)

January 1, 2013

Study Registration Dates

First Submitted

March 1, 2010

First Submitted That Met QC Criteria

March 1, 2010

First Posted (Estimate)

March 2, 2010

Study Record Updates

Last Update Posted (Estimate)

May 25, 2010

Last Update Submitted That Met QC Criteria

May 24, 2010

Last Verified

January 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MUW ADIP STUDY 16

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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