Discure Technologies Feasibility Study for DDD
Unknown statusNot applicableNCT06127745
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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).
Study details
- 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).
- Conditions
- Degenerative Disc Disease
- Chronic Low-back Pain
- Discogenic Pain
- Interventions
- Device: Discure System
- Sponsor
- Discure Technologies Ltd.
- Start date
- 2024-01
- Primary completion
- 2024-11
- Sex
- All
- Age range
- from 22 Years to 75 Years
- Results posted
- No results posted in this snapshot
- Total sites listed
- 0
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: 1. Participant is ≥ 22 and ≤75 years of age. 2. 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. 3. Participant has a documented diagnosis of early to moderate degenerative disc disease, confirmed by medical history, physical and neurological examination. 4. 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): 1. Chronic mechanical (axial) low back pain for at least 6 months 2. Have failed 3 months of conservative back pain care 3. 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. 5. 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) 6. Low back pain predominant over leg pain on a 100mm VAS scale 7. Oswestry disability index (ODI) score of at least 30 and no more than 90 on a 100- point scale. 8. Participant has the ability to comply with the instructions for use of the Discure System. 9. Participant is suitable for Discure system surgery as determined by the implanting physician prior to inclusion. 10. Participant is deemed to be neuro-psycho-socially appropriate for implantation. therapies based on a physician's assessment. Exclusion Criteria: 1. BMI \> 35 2. 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) * Back pain due to damage to the spinal cord or adjacent structures (e.g., arachnoiditis or syringomyelia) * Pathology seen on MRI, other …
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT06127745