Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

Tracking Information
First Submitted Date March 1, 2010
First Posted Date March 2, 2010
Last Update Posted Date May 25, 2010
Study Start Date January 2010
Estimated Primary Completion Date January 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 1, 2010)
Weight loss [ Time Frame: 2 years ]
Excessive weight loss
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Secondary Bypass Banding for Weight Regain or Weight Loss Failure After Lap. Gastric Bypass
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
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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
Condition Morbid Obesity
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
Other Name: A.M.I. Soft Gastric Band
Study Groups/Cohorts 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
Intervention: Device: Secondary Bypass Banding (adjustable A.M.I. Soft Gastric Band)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: March 1, 2010)
20
Original Estimated Enrollment Same as current
Estimated Study Completion Date January 2013
Estimated Primary Completion Date January 2013   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 20 Years to 60 Years   (Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Austria
Removed Location Countries  
 
Administrative Information
NCT Number NCT01078194
Other Study ID Numbers MUW ADIP STUDY 16
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Gerhard Prager / M.D., Medical University of Vienna / Department of Surgery
Study Sponsor Medical University of Vienna
Collaborators Not Provided
Investigators
Principal Investigator: Gerhard Prager, M.D. Medical University of Vienna, Department of Surgery
PRS Account Medical University of Vienna
Verification Date January 2010