Gastric Banding After Failed Gastric Bypass

Duomed

Status: Completed

Conditions: Obesity

Treatments: Device: Adhesix Bioring

Study type: Observational

Funder types: Industry

Identifiers

NCT02528565

BM-BA-01

Details and patient eligibility

About

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

Enrollment: 35 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

35 participants in 1 patient group

Patients with failed RYGB (EWL <50%)

Treatment:

Device: Adhesix Bioring