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RECRUITING
NCT04883411
NA

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

Sponsor: ReVivo Medical, Corp.

View on ClinicalTrials.gov

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.

Official title: First-in-human Prospective Study to Assess the Safety and Efficacy of the CEM-Cage and CEM-Plate

Key Details

Gender

All

Age Range

22 Years - 79 Years

Study Type

INTERVENTIONAL

Enrollment

50

Start Date

2022-03-07

Completion Date

2027-12

Last Updated

2025-04-18

Healthy Volunteers

No

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

Locations (4)

IGEA

Union, New Jersey, United States

Albany Medical College

Albany, New York, United States

University at Buffalo Neurosurgery

Williamsville, New York, United States

Cleveland Clinic

Cleveland, Ohio, United States