Discure Technologies Feasibility Study for DDD

NCT06127745 | Unknown

• 1 other identifier: CLN 002
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief 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).

Conditions

Degenerative Disc Disease; Chronic Low-back Pain; Discogenic Pain

Keywords

Discure System

Outcome Measures

Primary Outcomes (2)

• Safety- Serious Adverse Events

  Assessment of serious device and/or procedure related adverse events (SAE) in all participants.

  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.

  6 months

Secondary Outcomes (3)

• Patient Satisfaction

  6 months

• Participant Quality of Life

  6 months

• Pain Medication

  6 months

Study Arms (1)

Discure System

EXPERIMENTAL

All participants enrolled in the study will be treated with the Discure system

Device: Discure System

Interventions

Discure System DEVICE

All subjects enrolled into the study will be implanted with the Discure System in a minimally invasive procedure.

Discure System

Eligibility Criteria

• Age: 22 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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.

You may not qualify if:

• 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)
• 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 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)

Sponsors & Collaborators

• Discure Technologies Ltd.: lead

MeSH Terms

Conditions

Intervertebral Disc Degeneration

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Central Study Contacts

Shirley Giorini Silfen, PhD

CONTACT

+972.9.953 1125; shirley@discuremd.com

Yuval Mandelbaum

CONTACT

+972.9.953 1125; Yuval@discuremd.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: All enrolled participants will be treated with the Discure System

Study Record Dates

• First Submitted: November 7, 2023
• First Posted: November 13, 2023
• Study Start: January 1, 2024
• Primary Completion: November 1, 2024
• Study Completion: December 1, 2024
• Last Updated: November 14, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share