Gastric Banding After Failed Gastric Bypass

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02528565
• Other study ID #: BM-BA-01
• Status: Completed
• Start date: August 2015
• Est. completion date: December 9, 2019

Study information

• Verified date: February 2019
• Source: Duomed
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: December 9, 2019
• Est. primary completion date: December 9, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Obesity

Intervention

Device:
• Adhesix Bioring

Locations

Country	Name	City	State
Belgium	AZ Sint Jan Brugge	Brugge

Sponsors (2)

Lead Sponsor	Collaborator
Duomed	Archer Research

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage excess weight loss		2 years
Secondary	Technical success defined as laparoscopic implantation of the Adhesix Bioring as intended by the surgeon without conversion to open repair.		During procedure
Secondary	Complications (perioperative, early and late)		2 years
Secondary	Mortality		2 years
Secondary	Regression of co-morbidities		2 years
Secondary	BAROS score		2 years
Secondary	Frequency of revisions		2 years