CEM-Plate and CEM-Cage First-In-Human Use Efficacy Study (NCT04883411)
First-in-human Prospective Study to Assess the Safety and Efficacy of the CEM-Cage and CEM-Plate
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: IGEA — Union, New Jersey
Age range: 22 Years to 79 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (4 Sites)
- IGEA — Union, New Jersey
- Albany Medical College — Albany, New York
- University at Buffalo Neurosurgery — Williamsville, New York
- Cleveland Clinic — Cleveland, Ohio
📞 Contact the Study Coordinator
Phone: (518) 227-0743
Email: eledet@revivomedical.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.