CEM-Plate and CEM-Cage First-In-Human Use Efficacy Study

Recruiting N/A Interventional Study
Neck Pain Spondylosis Spondylosis With Myelopathy Spondylosis With Radiculopathy Spondylosis With Radiculopathy Cervical Region Intervertebral Disc Disorder Cervical
No Placebo Group Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
22 – 79
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
50 (estimated)
Sponsor
ReVivo Medical, Corp. · Industry
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About This Trial
The study is a prospective, first-in-human, multi-center, non-randomized, single-arm study to assess the safety and efficacy of the CEM-Cage used with the CEM-Plate in patients who are appropriate candidates for a 2-level anterior cervical discectomy and fusion (ACDF). Fifty patients will be enrolled in the study and, after undergoing a 2-level ACDF, will be evaluated at 4 weeks, 3 months, 6 month…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. Males and females aged 22-79 years. 2. Documented diagnosis of cervical spine radiculopathy or myelopathy. 3. Symptomatic cervical degenerative disc disease at 2 contiguous levels between C2 through T1. 4. Baseline NDI score ≥30 and/or baseline mJOA score ≤16. 5. Pathology at…
Contacts

Eric H Ledet, Ph.D.

5182270743

eledet@revivomedical.com

CONTACT