Gastric Banding After Failed Gastric Bypass

Completed

• Conditions: Obesity
• Interventions: Device: Adhesix Bioring

• Registration Number: NCT02528565
• Lead Sponsor: Duomed

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-07-15
• Study Start: 2015-08
• Study First Submitted QC: 2015-08-18
• Study First Posted: 2015-08-19
• Status Verified: 2019-02
• Primary Completion: 2019-12-09
• Study Completion: 2019-12-09
• Last Update Submitted: 2020-06-18
• Last Update Posted: 2020-06-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with failed RYGB (EWL <50%)	Adhesix Bioring	-

Primary Outcome Measures

Name	Time	Method
Percentage excess weight loss	2 years

Secondary Outcome Measures

Name	Time	Method
Complications (perioperative, early and late)	2 years
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
Regression of co-morbidities	2 years
BAROS score	2 years
Frequency of revisions	2 years

Trial Locations

Locations (1)

AZ Sint Jan Brugge; 🇧🇪 Brugge, Belgium