Lumbar Spinal StenosisNCT01053364
Feasibility Study of NL-Prow Interspinous Spacer to Treat Lumbar Spinal Stenosis
A study testing NL-Prow interspinous spacer implant in people with Lumbar Spinal Stenosis, run by Non-Linear Technologies at 1 site in Czechia.
Trial summary
The purpose of the study is to evaluate the clinical safety and feasibility of the NL-Prow™ Interspinous Spacer implant and insertion procedure in the treatment of lumbar spinal stenosis Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Lumbar Spinal Stenosis
- What is being tested?
- NL-Prow interspinous spacer implant
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteCzechia
- Study dates
- Jan 2010to Jul 2011
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women ≥50 years of age.
- Symptoms of leg/buttock/groin pain, with or without back pain, that are exacerbated by lumbar extension and relieved in flexion.
- Diagnosis of neurogenic intermittent claudication (NIC) (defined as a feeling of paresthesia and/or discomfort and/or pain and/or weakness in the leg(s) during walking or standing) secondary to lumbar spinal canal stenosis at 1-2 lumbar levels (between L1 and L5), confirmed by dynamic X-Ray (showing sagital instability or rocking), and CT and/or MRI (showing central spinal canal narrowing and/or foraminal narrowing).
- Has completed at least 6 months of conservative therapy, which may include but is not limited to, epidural steroid injections, oral steroids, NSAIDS, analgesics, physical therapy, spinal manipulation, bracing.
- Appropriate candidate for lumbar surgical treatment using posterior approach.
- Subject can walk independently 15 meters or more.
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- Subject is able to understand the risks and benefits of participating in the study.
- Subject understands and has signed the study informed consent form.
- Subject is physically and mentally willing and able to comply with the requirements of the study procedure and scheduled follow-up visits and testing.
Who cannot join
- Severe symptomatic lumbar spinal stenosis at ≥2 level, requiring surgical intervention.
- Prior lumbar spine surgery at any level.
- Unremitting pain in any spinal position or axial back pain only without leg/buttock/groin pain.
- Evidence that subject's symptoms are due to vascular claudication OR has significant peripheral vascular disease.
- Significant instability of the lumbar spine at any level OR defined as translation of more than 3mm or 10 degrees of angular motion between flexion and extension on upright lateral radiographs.
- Subject has an ankylosed segment at the affected level.
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- Significant scoliosis, defined as Cobb angle >25°.
- Cauda equina syndrome.
- Fixed motor deficit or known peripheral neuropathy demonstrated clinically.
- Subject has degenerative neurologic disease.
- Subject has any mass lesions.
- Any evidence of spinal or systemic infection.
- Subject has a history of spinous process fracture or pars interarticularis fractures or pathologic fractures of the vertebrae or multiple fractures of the vertebrae and/or hips
- Subject has history or radiographic evidence of 1 or more osteoporotic fractures in the spine.
- Subject has severe osteoporosis of the spine, defined as bone mineral density (BMD) in the spine more than 2.5 SD below the mean of adult normals.
- Subject is paraparetic.
- Subject has a bleeding disorder.
- Active systemic disease such as HIV, hepatitis, etc.
- Subject is immunologically suppressed, or has received or is receiving 7.5 milligrams prednisone (or equivalent) daily for more than six months immediately prior to enrollment.
- Extreme morbid obesity, defined as BMI >35 kg/m2.
- Diagnosis of lumbar spinal stenosis which requires a direct neural decompression or surgical intervention other than those required to implant the experimental device.
- Subject is not able to undergo MRI or tolerate closed MRI scan.
- Known or suspected history of alcohol and/or drug abuse.
- Life expectancy less than one year.
- Active rheumatoid arthritis.
Trial locations and contacts
1 site in 1 country.
Czechia1 site
Neurosurgery department, St. Anne's University Hospital
Brno, 656 91
About this study
Official title: Feasibility Study of NL-Prow Interspinous Spacer Device and Procedure
The purpose of the study is to evaluate the clinical safety and feasibility of the NL-Prow™ Interspinous Spacer implant and insertion procedure in the treatment of lumbar spinal stenosis
- Conditions
- Lumbar Spinal Stenosis
- Being tested
- NL-Prow interspinous spacer implant
- Medical subject headings
- Spinal Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NL-Prow interspinous spacer implantDevice
Interspinous spacer implant
| Study group | Role | What they receive |
|---|---|---|
| Implant | Experimental | Not described Receives: Device: NL-Prow interspinous spacer implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accurate placement of the interspinous spacer confirmed by fluoroscopy
Measured: Procedure completion
Secondary outcomes (2)
Improvement in leg and or back pain and in walking capability compared to baseline
Measured: One year
Any device and or procedure related adverse events or complications
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2010 (estimated)
- Study startJan 2010
- Primary completionJul 2011 (estimated)
- Study completionJul 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar Spinal StenosisStudies 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
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Non-Linear Technologies
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Zdenek Novak, MD, PhD, Principal investigator, St. Anne's University Hospital Brno, Czech Republic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01053364
- Sponsor's protocol ID
- NL-PROW-01
- Status last verified
- Jan 2011
- First submitted
- 19 Jan 2010
- Last updated
- 5 Jan 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study of NL-Prow Interspinous Spacer Device and Procedure
- ClinicalTrials.gov ID
- NCT01053364
- Acronym / sponsor ID
- NL-PROW-01
- Conditions
- Lumbar Spinal Stenosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Non-Linear TechnologiesIndustry (pharma, biotech, devices)
- Study start
- Jan 2010
- Primary completion
- Jul 2011 (estimated)
- Study completion
- Jul 2011 (estimated)
- First posted
- 21 Jan 2010 (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.
The purpose of the study is to evaluate the clinical safety and feasibility of the NL-Prow™ Interspinous Spacer implant and insertion procedure in the treatment of lumbar spinal stenosis
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Implant | Experimental | Device: NL-Prow interspinous spacer implant |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Men and women ≥50 years of age.
- Symptoms of leg/buttock/groin pain, with or without back pain, that are exacerbated by lumbar extension and relieved in flexion.
- Diagnosis of neurogenic intermittent claudication (NIC) (defined as a feeling of paresthesia and/or discomfort and/or pain and/or weakness in the leg(s) during walking or standing) secondary to lumbar spinal canal stenosis at 1-2 lumbar levels (between L1 and L5), confirmed by dynamic X-Ray (showing sagital instability or rocking), and CT and/or MRI (showing central spinal canal narrowing and/or foraminal narrowing).
- Has completed at least 6 months of conservative therapy, which may include but is not limited to, epidural steroid injections, oral steroids, NSAIDS, analgesics, physical therapy, spinal manipulation, bracing.
- Appropriate candidate for lumbar surgical treatment using posterior approach.
Key exclusion criteria (25 listed)
- Severe symptomatic lumbar spinal stenosis at ≥2 level, requiring surgical intervention.
- Prior lumbar spine surgery at any level.
- Unremitting pain in any spinal position or axial back pain only without leg/buttock/groin pain.
- Evidence that subject's symptoms are due to vascular claudication OR has significant peripheral vascular disease.
- Significant instability of the lumbar spine at any level OR defined as translation of more than 3mm or 10 degrees of angular motion between flexion and extension on upright lateral radiographs.
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 |
|---|---|---|
| NL-Prow interspinous spacer implantInterspinous spacer implant | Device | Implant |
Primary outcome
Accurate placement of the interspinous spacer confirmed by fluoroscopy
Time frame: Procedure completion
2 secondary outcomes
Improvement in leg and or back pain and in walking capability compared to baseline
Time frame: One year
Any device and or procedure related adverse events or complications
Time frame: One year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2011.
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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.
Zdenek Novak, MD, PhD principal investigator
St. Anne's University Hospital Brno, Czech Republic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NL-Prow interspinous spacer implant in people with Lumbar Spinal Stenosis, run by Non-Linear Technologies at 1 site in Czechia.
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 9 inclusion and 25 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: status not confirmed, as of the sponsor's last update on 5 Jan 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. 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?
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?
Accurate placement of the interspinous spacer confirmed by fluoroscopy (time frame: Procedure completion). 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 5 Jan 2011.