Gastric Banding After Failed Gastric Bypass | NCT02528565

Studies
Gastric Banding After Failed Gastric Bypass

NCT02528565

Sponsor

Duomed

Status

Completed

Last Update Posted

Jun 18, 2020Actual

Enrollment

35Actual

Phase

Not provided

Conditions

Obesity

Interventions

Adhesix Bioring

Countries

Belgium

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2015Actual

Primary Completion Date

Dec 9, 2019Actual

Completion Date

Dec 9, 2019Actual

First Submitted Date

Jul 15, 2015

First Submission Date that Met QC Criteria

Aug 18, 2015

First Posted Date

Aug 19, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 18, 2020

Last Update Posted Date

Jun 18, 2020Actual

Name	Class
Archer Research	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

2 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

35Actual

Label	Type	Description	Intervention Names
Patients with failed RYGB (EWL <50%)			Device: Adhesix Bioring

Name	Type	Description	Arm Group Labels	Other Names
Adhesix Bioring	Device		Patients with failed RYGB (EWL <50%)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage excess weight loss		2 years

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients with failed RYGB receiving revisional LAGB.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Bruno Dillemans, MD	AZ Sint-Jan AV	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
AZ Sint Jan Brugge		Bruges			Belgium

Condition Browse Module

MeSH Terms

ID	Term
D009765	Obesity

Ancestor Terms

ID	Term
D050177	Overweight
D044343	Overnutrition
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases

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Browse Branches

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