Gastric Banding After Failed Gastric Bypass

N/ACompletedNCT02528565

Duomed35 enrolled

Overview

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

Study Type

OBSERVATIONAL

Enrollment

Conditions

Obesity

Interventions

Adhesix BioringDEVICE

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

AZ Sint Jan Brugge

Bruges, Belgium

Outcomes

Primary Outcomes

Percentage excess weight loss

Time frame: 2 years

Secondary Outcomes

Technical success defined as laparoscopic implantation of the Adhesix Bioring as intended by the surgeon without conversion to open repair.

Time frame: During procedure

Complications (perioperative, early and late)

Time frame: 2 years

Mortality

Time frame: 2 years

Regression of co-morbidities

Time frame: 2 years

BAROS score

Time frame: 2 years

Frequency of revisions

Time frame: 2 years

Data from ClinicalTrials.gov

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