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NCT04883411 · ClinicalTrials.gov registry record · NA
CEM-Plate and CEM-Cage First-In-Human Use Efficacy Study
A NA study of Neck Pain and Spondylosis, sponsored by ReVivo Medical.
- Recruiting
- Registry status
- NA
- Development phase
- 50
- Enrollment target
- 4
- Study locations
NCT04883411: Recruiting NA study of Neck Pain and Spondylosis, sponsored by ReVivo Medical.
NCT04883411 is a NA study of Neck Pain and Spondylosis that is actively recruiting participants, run by ReVivo Medical. The registered enrollment target is 50 participants, below the 1,189-participant average among 31 other Neck Pain trials with a reported enrollment target (96% lower). The trial reports 4 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04883411, a NA study of Neck Pain and Spondylosis, is actively recruiting participants, sponsored by ReVivo Medical.
- RECRUITING
- Registry status
- NA
- Development phase
- 50 participants
- Enrollment target
- 4
- Study locations
Study Summary
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.
Primary Outcome
Flexion-extension plain radiographs and CT scans will be used to assess bony fusion at both surgical levels.
Conditions Studied
Interventions
- DEVICE CEM-Plate Anterior Cervical Plating System and CEM-Cage Cervical Interbody System
Study Locations (4)
New York
- Albany Medical College - Albany
- University at Buffalo Neurosurgery - Williamsville
New Jersey
- IGEA - Union
Ohio
- Cleveland Clinic - Cleveland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2022-03-07 |
| Est. Completion | 2027-12 |
| Phase | NA |
What NCT04883411 shows while recruiting
NCT04883411 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 1,189-participant average among 31 other Neck Pain trials with a reported enrollment target (96% lower).
The record links to 6 conditions, with Neck Pain appearing as the primary indexed condition, and to 1 intervention - of which CEM-Plate Anterior Cervical Plating System and CEM-Cage Cervical Interbody System is the first listed.
NCT04883411 reports a single indexed study location in New York, New Jersey, Ohio.
Frequently Asked Questions
What is clinical trial NCT04883411 about?
NCT04883411 is a clinical study titled "CEM-Plate and CEM-Cage First-In-Human Use Efficacy Study". 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 enrolle...
What is the current status of trial NCT04883411?
This trial is currently recruiting. It is a NA study. The enrollment target is 50 participants. The study started on 2022-03-07. Estimated completion is 2027-12.
What conditions does trial NCT04883411 study?
This clinical trial studies the following conditions: Neck Pain, Spondylosis, Spondylosis With Myelopathy, Spondylosis With Radiculopathy, Spondylosis With Radiculopathy Cervical Region.
What interventions are being tested in trial NCT04883411?
The interventions under investigation include: CEM-Plate Anterior Cervical Plating System and CEM-Cage Cervical Interbody System (DEVICE).
Who is sponsoring clinical trial NCT04883411?
This trial is sponsored by ReVivo Medical, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04883411 being conducted?
This trial has 4 study locations across New Jersey, New York, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04883411's enrollment target sits among peer trials
50 20th of 31 higher than 12 of 31 other Neck Pain trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Neck Pain trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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