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CEM-Plate and CEM-Cage First-In-Human Use Efficacy Study

NCT04883411 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2025-04-18

No results posted yet for this 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

  • Neck Pain
  • Spondylosis
  • Spondylosis With Myelopathy
  • Spondylosis With Radiculopathy
  • Spondylosis With Radiculopathy Cervical Region
  • Intervertebral Disc Disorder Cervical

Interventions

DEVICE

CEM-Plate Anterior Cervical Plating System and CEM-Cage Cervical Interbody System

Two-Level ACDF with CEM-Plate Anterior Cervical Plating System and CEM-Cage Cervical Interbody System

Sponsors & Collaborators

  • Albany Medical College

    collaborator OTHER

  • The Cleveland Clinic

    collaborator OTHER

  • IGEA

    collaborator INDUSTRY

  • ReVivo Medical, Corp.

    lead INDUSTRY

Principal Investigators

  • John German, MD · Albany Medical College

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
22 Years
Max Age
79 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-07
Primary Completion
2027-08-31
Completion
2027-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04883411 on ClinicalTrials.gov