NCT02528565

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 15, 2015

Completed
17 days until next milestone

Study Start

First participant enrolled

August 1, 2015

Completed
18 days until next milestone

First Posted

Study publicly available on registry

August 19, 2015

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 9, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 9, 2019

Completed
Last Updated

June 18, 2020

Status Verified

February 1, 2019

Enrollment Period

4.4 years

First QC Date

July 15, 2015

Last Update Submit

June 18, 2020

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

  • Percentage excess weight loss

    2 years

Secondary Outcomes (6)

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

    During procedure

  • Complications (perioperative, early and late)

    2 years

  • Mortality

    2 years

  • Regression of co-morbidities

    2 years

  • BAROS score

    2 years

  • +1 more secondary outcomes

Study Arms (1)

Patients with failed RYGB (EWL <50%)

Device: Adhesix Bioring

Interventions

Adhesix BioringDEVICE
Patients with failed RYGB (EWL <50%)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with failed RYGB receiving revisional LAGB.

You may qualify if:

  • Patient must sign the informed consent form prior to the index-procedure.
  • Patient with failed RYGB defined as patients with EWL \<50%.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AZ Sint Jan Brugge

Bruges, Belgium

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Bruno Dillemans, MD

    AZ Sint-Jan AV

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
2 Years
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 15, 2015

First Posted

August 19, 2015

Study Start

August 1, 2015

Primary Completion

December 9, 2019

Study Completion

December 9, 2019

Last Updated

June 18, 2020

Record last verified: 2019-02

Locations

BE(1)