Degenerative Disc DiseaseNCT06127745
Discure Technologies Feasibility Study for DDD
A study testing Discure System in people with Degenerative Disc Disease and Chronic Low-back Pain, run by Discure Technologies Ltd..
Trial summary
The objective of this study is to evaluate the safety and performance of the Discure System therapy in subjects with early to moderate degeneration of the disc (DDD). Read more about this study
- Who is it for?
- Ages 22 to 75 years
- Conditions the study is for
- Degenerative Disc Disease, Chronic Low-back Pain, Discogenic Pain
- What is being tested?
- Discure System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Jan 2024to Dec 2024
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participant is ≥ 22 and ≤75 years of age.
- If female of childbearing potential, participant is non-pregnant, non-nursing, and agrees to use highly effective methods of contraception for a minimum of 24 months post-treatment.
- Participant has a documented diagnosis of early to moderate degenerative disc disease, confirmed by medical history, physical and neurological examination.
- Participant has a discogenic mechanical Low Back Pain (LBP) of an intervertebral disc/s from L1 to S1, based on the following (participant must meet all the listed conditions):
- Chronic mechanical (axial) low back pain for at least 6 months
- Have failed 3 months of conservative back pain care
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- Change from normal disc morphology of the index disc as defined on magnetic resonance imaging (MRI) and Xray evaluation must show the following:
- Single level or up to two symptomatic (causing chronic LBP) discs from L1 to S1
- A modified Pfirrmann score of 3, 4, 5 or 6 on magnetic resonance imaging (MRI) at the index disc/s.
- Modic Grade II changes or less on MRI at the index disc.
- With or without contained disc protrusion, with no nerve compression, at the index disc on MRI.
- Low back pain of at least 40mm and not more than 90mm of 100mm on low back pain visual analogue scale (VAS) (average pain over 7 days diary)
- Low back pain predominant over leg pain on a 100mm VAS scale
- Oswestry disability index (ODI) score of at least 30 and no more than 90 on a 100- point scale.
- Participant has the ability to comply with the instructions for use of the Discure System.
- Participant is suitable for Discure system surgery as determined by the implanting physician prior to inclusion.
- Participant is deemed to be neuro-psycho-socially appropriate for implantation. therapies based on a physician's assessment.
Who cannot join
- BMI > 35
- Back Pain characteristics:
- Any surgical correction procedure for scoliosis at any time, or a current clinical diagnosis of scoliosis
- Lumbar spine stenosis, as defined by an anterior-posterior diameter of the spinal canal of <10mm in participants with lower extremity pain
- Neurological deficit possibly associated with the back pain (e.g. foot drop)
- Back pain due to pelvic or visceral reasons (e.g.: endometriosis or fibroids) or infection (e.g.: post herpetic neuralgia)
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- Back pain due to damage to the spinal cord or adjacent structures (e.g., arachnoiditis or syringomyelia)
- Pathology seen on MRI, other than DDD, that is clearly identified and is likely the cause of the Chronic Low Back Pain (CLBP) that is surgical.
- Back pain due to other causes, such as vascular (e.g., aortic aneurysm and dissection), GI, GYU, oncological etc.
- Source of pain is the sacroiliac joint or facet joint as determined by the Investigator.
- Any prior diagnosis of lumbar vertebral compression fracture, lumbar pars fracture, or lumbar annular tear with disc protrusion of the target operative disc, that is surgical.
- Participant has lumbar spondylitis or other undifferentiated spondyloarthropathy at the target disc.
- Participant has had previous lumbar spine surgery at level L1-2 to L5-S1
- Participant has had previous disc invasive treatment procedures, into the target disc/s, except for contrast media-discography performed at least 2 weeks prior to study enrollment.
- Participant has symptomatic involvement of more than two lumbar discs or more than two lumbar discs that satisfy the radiographic profile defined in the Inclusion Criteria
- Participant has current infection at the planned procedure site, active systemic infection, or current or prior history of lumbar spinal infection (i.e., discitis, septic arthritis, epidural abscess)
- Participant is at higher risk for post-surgical infection (e.g., taking immunosuppressants, has a severe infection or a history of serious infection)
- Participant has an active malignancy or tumor.
- Participant has had significant systemic disease, such as unstable angina, autoimmune disease, rheumatoid arthritis, diabetes mellitus-insulin dependent, or muscular dystrophy.
- Participant has a congenital or acquired coagulopathy or thrombocytopenia.
- Participant is currently taking anticoagulant, antineoplastic, antiplatelet, or thrombocytopenia inducing medications (except for aspirin or nonsteroidal anti- inflammatory drugs [NSAIDS])
- Participant has concomitant conditions requiring daily oral steroid usage for more than 30 days in the preceding 90 days before enrollment.
- Participant has an uncontrolled psychiatric condition: bipolar disorder, post-traumatic stress disorder (PTSD) or uncontrolled anxiety/depression and/or require new or changed anti-depressants or anti-psychotic medications within 3 months of enrollment.
- Participant has evidence of substance/ alcohol abuse that would potentially interfere with the participant's participation in the study within 3 months prior to enrollment.
- Participant has or requires non-MRI compatible devices, such as an implantable electronic defibrillator, pacemaker, or has other contraindication to MRI scanning or cannot tolerate MRI scanning. Participants who are expected to require a defibrillator or pacemaker within the first 6 months of the study should be excluded.
- Compensation injuries or ongoing litigation regarding back pain/ injury, or financial or other incentives to remain impaired.
- Participant is currently enrolled in or plans to enroll in any concurrent drug, and/or biological, and/or device study while participating in this study.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Prospective Study to Assess the Safety and Performance of the Discure Technologies System for the Treatment of Early to Moderate Degenerative Disc Disease (DDD).
The objective of this study is to evaluate the safety and performance of the Discure System therapy in subjects with early to moderate degeneration of the disc (DDD).
Read the detailed description
A prospective, interventional, multi-center, single arm, open label, feasibility study. The study is designed to evaluate the safety and performance of the Discure System in the treatment of chronic low back pain (with or without radicular pain) of discogenic origin with early to moderate degeneration of the disc (DDD) in levels L1-2 to L5-S1, as confirmed by history and radiographic studies and/or discography, who failed conservative treatment of 12 weeks in duration.
Subjects will be followed at 1,3-, and 6-months post procedure. The primary endpoint will be assessed at the 6-month follow-up visit.
The study will enroll up to 20 subjects at up to 8 sites.
- Being tested
- Discure System
- Keywords
- Discure System
- Medical subject headings
- Intervertebral Disc Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Discure SystemDevice
All subjects enrolled into the study will be implanted with the Discure System in a minimally invasive procedure.
| Study group | Role | What they receive |
|---|---|---|
| Discure System | Experimental | All participants enrolled in the study will be treated with the Discure system Receives: Device: Discure System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety- Serious Adverse Events
Assessment of serious device and/or procedure related adverse events (SAE) in all participants.
Measured: 6 months
Performance
The change from baseline in functional disability on the Oswestry Disability Index (ODI) measured from 0 (minimal disability) to 100 (maximal disability) OR The mean change of low back pain as measured by a 0 (no pain)-100 mm (worst pain) Visual Analogue Scale (VAS) 7-day diary from baseline to primary endpoint visit.
Measured: 6 months
Secondary outcomes (3)
Patient Satisfaction
The change in patient satisfaction as measured by Patient Global Impression of Change (PGIC) from baseline to 6 months visit.
Measured: 6 months
Participant Quality of Life
The change in Quality of Life as measured by the European Quality of Life Five 5 Dimension (EQ-5D) from baseline to 6 months visit, scored from 100 ('the best health state you can imagine') to 0 ('the worst health you can imagine').
Measured: 6 months
Pain Medication
Pain medication usage reduction
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 posted13 Nov 2023
- Study startJan 2024 (estimated)
- Primary completionNov 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Degenerative Disc DiseaseStudies 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
- Model description
- All enrolled participants will be treated with the Discure System
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Discure Technologies Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06127745
- Sponsor's protocol ID
- CLN 002
- Status last verified
- Nov 2023
- First submitted
- 7 Nov 2023
- Last updated
- 14 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study to Assess the Safety and Performance of the Discure Technologies System for the Treatment of Early to Moderate Degenerative Disc Disease (DDD).
- ClinicalTrials.gov ID
- NCT06127745
- Acronym / sponsor ID
- CLN 002
- Keywords
- Discure System
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Discure Technologies Ltd.Industry (pharma, biotech, devices)
- Study start
- Jan 2024 (estimated)
- Primary completion
- Nov 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 13 Nov 2023 (actual)
- 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 objective of this study is to evaluate the safety and performance of the Discure System therapy in subjects with early to moderate degeneration of the disc (DDD).
Detailed description
A prospective, interventional, multi-center, single arm, open label, feasibility study. The study is designed to evaluate the safety and performance of the Discure System in the treatment of chronic low back pain (with or without radicular pain) of discogenic origin with early to moderate degeneration of the disc (DDD) in levels L1-2 to L5-S1, as confirmed by history and radiographic studies and/or discography, who failed conservative treatment of 12 weeks in duration.
Subjects will be followed at 1,3-, and 6-months post procedure. The primary endpoint will be assessed at the 6-month follow-up visit.
The study will enroll up to 20 subjects at up to 8 sites.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All enrolled participants will be treated with the Discure System
| Arm | Type | Receives |
|---|---|---|
| Discure System | Experimental | Device: Discure SystemAll participants enrolled in the study will be treated with the Discure system |
Who may qualify
- Ages
- 22 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Participant is ≥ 22 and ≤75 years of age.
- If female of childbearing potential, participant is non-pregnant, non-nursing, and agrees to use highly effective methods of contraception for a minimum of 24 months post-treatment.
- Participant has a documented diagnosis of early to moderate degenerative disc disease, confirmed by medical history, physical and neurological examination.
- Participant has a discogenic mechanical Low Back Pain (LBP) of an intervertebral disc/s from L1 to S1, based on the following (participant must meet all the listed conditions):
- Low back pain of at least 40mm and not more than 90mm of 100mm on low back pain visual analogue scale (VAS) (average pain over 7 days diary)
Key exclusion criteria (27 listed)
- BMI > 35
- Back Pain characteristics:
- Source of pain is the sacroiliac joint or facet joint as determined by the Investigator.
- Any prior diagnosis of lumbar vertebral compression fracture, lumbar pars fracture, or lumbar annular tear with disc protrusion of the target operative disc, that is surgical.
- Participant has lumbar spondylitis or other undifferentiated spondyloarthropathy at the target disc.
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 |
|---|---|---|
| Discure SystemAll subjects enrolled into the study will be implanted with the Discure System in a minimally invasive procedure. | Device | Discure System |
Primary outcome
Safety- Serious Adverse Events
Time frame: 6 months
Assessment of serious device and/or procedure related adverse events (SAE) in all participants.
Performance
Time frame: 6 months
The change from baseline in functional disability on the Oswestry Disability Index (ODI) measured from 0 (minimal disability) to 100 (maximal disability) OR The mean change of low back pain as measured by a 0 (no pain)-100 mm (worst pain) Visual Analogue Scale (VAS) 7-day diary from baseline to primary endpoint visit.
3 secondary outcomes
Patient Satisfaction
Time frame: 6 months
Participant Quality of Life
Time frame: 6 months
Pain Medication
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2023.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Discure System in people with Degenerative Disc Disease and Chronic Low-back Pain, run by Discure Technologies Ltd..
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 17 inclusion and 27 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 14 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Shirley Giorini Silfen, PhD (+972.9.953 1125, shirley@discuremd.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety- Serious Adverse Events (time frame: 6 months). The study lists 2 primary outcomes in all. 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 14 Nov 2023.