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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 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.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04883411
The ClinicalTrials.gov registry entry for NCT04883411 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 50 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,189-participant average among 31 other Neck Pain trials with a reported enrollment target (96% lower). The listed sponsor is ReVivo Medical, which has 1 total studies on file at ClinicalTrials.gov.
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 4 study locations spanning 3 distinct geographic areas - top geographies include 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.
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Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.