RecruitingNot ApplicableNCT04883411

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

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


Sponsor

ReVivo Medical, Corp.

Enrollment

50 participants

Start Date

Mar 7, 2022

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 22 YearsMax Age: 79 Years

Plain Language Summary

Simplified for easier understanding

This study is evaluating the safety and effectiveness of a new cervical spine implant system (the CEM-Plate and CEM-Cage) in patients who need surgery for a degenerative disc disease or nerve compression in the neck involving two adjacent spinal levels. It is the first time this device is being used in humans. You may be eligible if: - You are between 22 and 79 years old - You have a diagnosed condition such as cervical radiculopathy (nerve pain from the neck) or myelopathy (spinal cord compression) - You have degeneration at exactly 2 adjacent cervical spine levels between C2 and T1 - Your symptoms have not improved with at least 6 weeks of non-surgical treatment, or you have worsening myelopathy - Your NDI score is 30 or higher, or your mJOA score is 16 or lower You may NOT be eligible if: - You have had prior cervical spine surgery at any level - You have osteoporosis, Paget disease, or other metabolic bone diseases - You have a BMI over 40 - You are pregnant - You have active cancer or a current infection - You smoke more than 1 pack of cigarettes per day - You have significant mental illness or substance abuse issues Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICECEM-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

View Full Details on ClinicalTrials.gov

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NCT04883411


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