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NCT01078194 Clinical Trial

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

Morbid Obesity Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT01078194
Other study ID # MUW ADIP STUDY 16
Secondary ID
Status Recruiting
Phase N/A
First received March 1, 2010
Last updated May 24, 2010
Start date January 2010
Est. completion date January 2013

Study information
Verified date January 2010
Source Medical University of Vienna
Contact Gerhard Prager, M.D.
Phone +43-1-40400
Email gerhard.prager@meduniwien.ac.at
Is FDA regulated No
Health authority Austria: Ethikkommission
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 20
Est. completion date January 2013
Est. primary completion date January 2013
Accepts healthy volunteers No
Gender Both
Age group 20 Years to 60 Years
Eligibility 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 Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Austria Medical University of Vienna, Department of Surgery Vienna

Sponsors (1)
Lead Sponsor Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome
Type Measure Description Time frame Safety issue
Primary Weight loss Excessive weight loss 2 years No
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