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Discure Technologies Feasibility Study for DDD

20 participantsStarted 2024-01

Plain-language 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).

Who can participate

Age range22 Years – 75 Years

SexALL

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Inclusion criteria

✓. 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
✓. Change from normal disc morphology of the index disc as defined on magnetic resonance imaging (MRI) and Xray evaluation must show the following:
✓. 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)

Exclusion criteria

✕. 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.
✕. 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

What they're measuring

Safety- Serious Adverse Events

Timeframe: 6 months

Performance

Timeframe: 6 months

Trial details

NCT IDNCT06127745

SponsorDiscure Technologies Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-11

Contact for this trial

Shirley Giorini Silfen, PhD

+972.9.953 1125 shirley@discuremd.com

View on ClinicalTrials.gov More Degenerative Disc Disease trials