A Multi-Site Study of the Zyga GlyDer Facet Restoration D... | NCT02179476

Studies
A Multi-Site Study of the Zyga GlyDer Facet Restoration Device In Subjects With LUmbar FacET Pain Syndrome - DUET

NCT02179476

Sponsor

Zyga Technology, Inc.

Status

Terminated

Last Update Posted

Oct 11, 2018Actual

Enrollment

2Actual

Phase

Not Applicable

Conditions

Facet Joint Pain

Interventions

Glyder

Countries

United States

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

Oct 2018

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

No additional enrollment

Expanded Access Info

Start Date

Jun 2014

Primary Completion Date

Dec 2017Actual

Completion Date

Sep 2018Actual

First Submitted Date

Jan 28, 2013

First Submission Date that Met QC Criteria

Jun 30, 2014

First Posted Date

Jul 1, 2014Estimated

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

Oct 10, 2018

Last Update Posted Date

Oct 11, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

A non-randomized, multi-site feasibility study to evaluate the safety of the Glyder Device in subjects with a history of lumbar facet joint disease (L2 to the sacrum) and successful neural ablation in which the facet joint is confirmed as the source of pain.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

2Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Glyder	Experimental	Glyder Facet Restoration Device	Device: Glyder

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Glyder	Device	The Glyder Facet Restoration Device is intended for minimally invasive bilateral implantation in one or two lumbar facet levels	Glyder

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Primary Safety Endpoint	Safety will be evaluated by assessing the incidence of device and/or procedure related serious adverse events.	6 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Key Inclusion Criteria:

Confirmed bilateral facet joint disease demonstrated by a successful facet rhizotomy (neural ablation) within 18 months prior to enrollment
Facet pain is limited to one to two levels from L2 to the sacrum and pain is bilateral
Two diagnostic injections (MBBs) both resulting in 80% relief to confirm back pain is facetogenic
VAS back pain of ≥ 60 mm on a 100 mm scale, and VAS back pain is greater than or equal to the highest VAS leg pain score
ODI ≥ 20 points
At least six (6) months of non-operative conservative management (Analgesic therapy for a minimum of 2 weeks and a minimum of 4 weeks of NSAID therapy; Supervised exercise and/or physical therapy program-minimum of 12 sessions)
At least 22 years of age and skeletally mature

Key Exclusion Criteria:

Pain is from a spinal structure other than facet joints (i.e., disc, hip and SI joint pain are excluded)
Osteoporosis or severe osteopenia
Lumbar fusion
Symptomatic spinal stenosis requiring surgical intervention
Prior total disc replacement, fusion, decompressive laminectomy, facetectomy, or placement of a posterior spinous process device
Disc herniation requiring surgical intervention
The subject has a Body Mass Index (BMI) of greater than 35
Planned elective surgery within 12 months

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

22 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
The Spine Institute		Santa Monica	California	90403	United States
Laser Spine Institute

Condition Browse Module

MeSH Terms

ID	Term
D017116	Low Back Pain
D001416	Back Pain

Ancestor Terms

ID	Term
D010146	Pain
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided