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Banded Versus Conventional Laparoscopic Roux-en-Y (GABY)

NCT01015469 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 384

Last updated 2011-02-17

No results posted yet for this study

Summary

Banded Versus Conventional Laparoscopic Roux-en-Y Gastric Bypass (GABY).

The aim of this novel study is to evaluate, if an additional restrictive silastic ring can avoid dilation of the gastro-entero anastomosis and adjacent small bowel with consecutive better postoperative weight loss and significantly improved long-term weight maintenance.

The study will not investigate the GaBP-Ring as medical product but the effect of the GaBP-Ring on weight loss in comparison to gastric bypass alone.

Conditions

  • Morbid Obesity Requiring Bariatric Surgery

Interventions

PROCEDURE

Conventional laparoscopic Roux-en-Y gastric bypass

Conventional laparoscopic Roux-en-Y gastric bypass

PROCEDURE

conventional laparoscopic Roux-en-Y gastric bypass with additional restrictive silastic ring

conventional laparoscopic Roux-en-Y gastric bypass with additional restrictive silastic ring (GaBP-Ring)

Sponsors & Collaborators

  • ClinTrio Ltd.

    lead OTHER

Principal Investigators

  • Konrad W Karcz, MD · Albert-Ludwigs-University of Freiburg

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-02-28
Primary Completion
2014-03-31
Completion
2015-03-31

Countries

  • Austria
  • Belgium
  • Germany
  • Netherlands
  • Poland
  • Portugal
  • Saudi Arabia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01015469 on ClinicalTrials.gov