Actively Recruiting
CEM-Plate and CEM-Cage First-In-Human Use Efficacy Study
Led by ReVivo Medical, Corp. · Updated on 2025-04-18
50
Participants Needed
4
Research Sites
299 weeks
Total Duration
On this page
Sponsors
R
ReVivo Medical, Corp.
Lead Sponsor
A
Albany Medical College
Collaborating Sponsor
AI-Summary
What this Trial Is About
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 months, 12 months, 18 months, and 24 months.
CONDITIONS
Official Title
CEM-Plate and CEM-Cage First-In-Human Use Efficacy Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Males and females aged 22-79 years
- Diagnosed with cervical spine radiculopathy or myelopathy
- Symptomatic cervical degenerative disc disease at 2 contiguous levels between C2 through T1
- Baseline Neck Disability Index (NDI) score of 30 or higher and/or modified Japanese Orthopaedic Association (mJOA) score of 16 or lower
- Imaging confirms pathology at the treated level correlating with symptoms
- Unresponsive to at least 6 weeks of conservative treatment or have progressive myelopathy or signs of nerve/spinal cord compression despite treatment
- Able to understand, speak, and read the informed consent document
- Willing to provide informed consent to participate
You will not qualify if you...
- Prior cervical surgeries or fusion at the symptomatic levels
- Treatment required at fewer or more than 2 vertebral levels
- Anatomy unsuitable for receiving the investigational device
- More than one immobile vertebral level between C1 and C7 from any cause
- Known osteoporosis or current osteoporosis treatment that contraindicates surgery
- Paget disease, osteomalacia, or other metabolic bone diseases aside from osteoporosis
- Active or recent invasive malignancy (except certain skin cancers) unless treated and symptom-free for over 5 years
- Severe cervical instability requiring anterior and posterior procedures
- Decompression needing corpectomy at one or more levels
- Active infections systemically or at implant site
- Open wounds or local inflammation
- Fever
- Conditions preventing accurate clinical evaluation
- Daily or chronic use of high-dose oral or inhaled steroids
- Body mass index over 40
- Use of other investigational drugs or devices within 30 days prior to surgery
- Smoking more than one pack of cigarettes per day
- Mental illness preventing study participation
- History or current substance abuse needing intervention
- Legal issues related to spinal injury or worker's compensation
- History or anticipated treatment for systemic infections including HIV or Hepatitis C
- Previous trauma causing significant injury to C2 to T1 levels
- Neck pain alone without radiculopathy or myelopathy symptoms needing surgery
- Pregnancy
- Medical or surgical conditions preventing benefit from spinal implant surgery
- Known metal allergy or intolerance
- Inadequate tissue coverage, bone stock, quality, or anatomical definition at operative site
- Unwilling to follow post-operative instructions
- Implant use interfering with anatomical or physiological function
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
IGEA
Union, New Jersey, United States, 07083
Actively Recruiting
2
Albany Medical College
Albany, New York, United States, 12208
Actively Recruiting
3
University at Buffalo Neurosurgery
Williamsville, New York, United States, 14221
Actively Recruiting
4
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Actively Recruiting
Research Team
E
Eric H Ledet, Ph.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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