Facet Joint PainDUETNCT02179476
A Multi-Site Study of the Zyga GlyDer Facet Restoration Device In Subjects With LUmbar FacET Pain Syndrome - DUET
A study testing Glyder in people with Facet Joint Pain, run by Zyga Technology, Inc. at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Facet Joint Pain
- What is being tested?
- Glyder
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 4 sitesUnited States
- Study dates
- Jun 2014to Sep 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Clinical Radiology of Oklahoma
Edmond, Oklahoma, 73083
The Spine Institute
Santa Monica, California, 90403
Northwest Orthopaedic Specialists
Spokane, Washington, 99208
Laser Spine Institute
Tampa, Florida, 33607
About this study
Official title: A Multi-Site Study of the Zyga GlyDer Facet Restoration Device In Subjects With LUmbar FacET Pain Syndrome (DUET)
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.
- Conditions
- Facet Joint Pain
- Being tested
- Glyder
- Keywords
- Facet joint, facet joint pain, facet joint disease, lumbar pain, back pain
- Medical subject headings
- Low Back Pain, Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GlyderDevice
Also called Glyder Facet Restoration Device, Glyder Device
The Glyder Facet Restoration Device is intended for minimally invasive bilateral implantation in one or two lumbar facet levels
| Study group | Role | What they receive |
|---|---|---|
| Glyder | Experimental | Glyder Facet Restoration Device Receives: Device: Glyder |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Safety Endpoint
Safety will be evaluated by assessing the incidence of device and/or procedure related serious adverse events.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2014 (estimated)
- Study startJun 2014
- Primary completionDec 2017
- Study completionSep 2018
Why it stopped: No additional enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Facet Joint PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zyga Technology, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02179476
- Sponsor's protocol ID
- DUET 001-003
- Acronym
- DUET
- Status last verified
- Oct 2018
- First submitted
- 28 Jan 2013
- Last updated
- 11 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Site Study of the Zyga GlyDer Facet Restoration Device In Subjects With LUmbar FacET Pain Syndrome (DUET)
- ClinicalTrials.gov ID
- NCT02179476
- Acronym / sponsor ID
- DUET / DUET 001-003
- Conditions
- Facet Joint Pain
- Keywords
- Facet joint, facet joint pain, facet joint disease, lumbar pain, back pain
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: No additional enrollment
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Zyga Technology, Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2014
- Primary completion
- Dec 2017 (actual)
- Study completion
- Sep 2018 (actual)
- First posted
- 1 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Glyder | Experimental | Device: GlyderGlyder Facet Restoration Device |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GlyderAlso: Glyder Facet Restoration Device, Glyder DeviceThe Glyder Facet Restoration Device is intended for minimally invasive bilateral implantation in one or two lumbar facet levels | Device | Glyder |
Primary outcome
Primary Safety Endpoint
Time frame: 6 months
Safety will be evaluated by assessing the incidence of device and/or procedure related serious adverse events.
Results and safety
The study was stopped early (reason given: No additional enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Glyder in people with Facet Joint Pain, run by Zyga Technology, Inc. at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 11 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: No additional enrollment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Safety Endpoint (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Oct 2018.