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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02528565

Enrollment

Registered

2015-08-19

Start date

2015-08-31

Completion date

2019-12-09

Last updated

2020-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity

Brief summary

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

Interventions

DEVICEAdhesix Bioring

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Percentage excess weight loss	2 years

Secondary

Measure	Time frame
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
BAROS score	2 years
Frequency of revisions	2 years
Regression of co-morbidities	2 years

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026