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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.

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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.

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

FieldValue
Enrollment Target 50 participants
Start Date 2022-03-07
Est. Completion 2027-12
Phase NA

Sponsor

ReVivo Medical

1 total trials

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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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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