Gastric Banding After Failed Gastric Bypass

Laparoscopic Adjustable Gastric Banding With the Adhesix Bioring After Failed Gastric Bypass: a Prospective Evaluation in a High-volume Center

The safety and efficacy of the Adhesix Bioring adjustable gastric band will be assessed in patients after failed RYGB.

Study Overview

• Status: Completed
• Conditions: Obesity
• Intervention / Treatment: Device: Adhesix Bioring

• Study Type: Observational
• Enrollment (Actual): 35

Contacts and Locations

Study Locations

• Belgium
  • Brugge, Belgium
    • AZ Sint Jan Brugge

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with failed RYGB receiving revisional LAGB.

Description

Inclusion Criteria:

• Patient must sign the informed consent form prior to the index-procedure.
• Patient with failed RYGB defined as patients with EWL <50%.

Exclusion Criteria:

• Patient has a life expectancy of less than 2 year.
• Patient who is most likely expected not to be compliant with the proposed follow-up visits.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients with failed RYGB (EWL <50%)	Device: Adhesix Bioring

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percentage excess weight loss	2 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Mortality	2 years
Technical success defined as laparoscopic implantation of the Adhesix Bioring as intended by the surgeon without conversion to open repair.	During procedure
Complications (perioperative, early and late)	2 years
Regression of co-morbidities	2 years
BAROS score	2 years
Frequency of revisions	2 years

Collaborators and Investigators

• Sponsor: Duomed
• Collaborators: Archer Research
• Investigators: Principal Investigator: Bruno Dillemans, MD, AZ Sint-Jan AV

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2015
• Primary Completion (Actual): December 9, 2019
• Study Completion (Actual): December 9, 2019

Study Registration Dates

• First Submitted: July 15, 2015
• First Submitted That Met QC Criteria: August 18, 2015
• First Posted (Estimate): August 19, 2015

Study Record Updates

• Last Update Posted (Actual): June 18, 2020
• Last Update Submitted That Met QC Criteria: June 18, 2020
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: BM-BA-01