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

Part of paid clinical trials in Union, New Jersey.

Sponsor
ReVivo Medical, Corp.
Study ID
NCT04883411
Status
Recruiting
Apply to this trial

Conditions

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

Eligibility Criteria

Sex
ALL
Age
22 Years - 79 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Mar 7, 2022
Status verified
Apr 2025
Primary completion
Aug 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
50 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment
    Two-Level ACDF with CEM-Plate Anterior Cervical Plating System and CEM-Cage Cervical Interbody System.

Primary Outcome Measure

Fusion [ Time Frame: 24 months. ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
IGEAUnionNew Jersey07083
Adam Lipson, MD
Adam Lipson, MD (PRINCIPAL_INVESTIGATOR)
Albany Medical CollegeAlbanyNew York12208
John German, MD
[email protected]
Darryl DiRisio, MD (SUB_INVESTIGATOR)
Robert Cheney, MD (SUB_INVESTIGATOR)
John German, MD (PRINCIPAL_INVESTIGATOR)
John Dalfino, MD (SUB_INVESTIGATOR)
Frank Genovese, MD (SUB_INVESTIGATOR)
Ahmed Meleis, MD (SUB_INVESTIGATOR)
Alexander Riccio, MD (SUB_INVESTIGATOR)
University at Buffalo NeurosurgeryWilliamsvilleNew York14221
John Pollina, MD
John Pollina, MD (PRINCIPAL_INVESTIGATOR)
Jeffrey Mullin, MD (SUB_INVESTIGATOR)
Cleveland ClinicClevelandOhio44195
Dominic Pelle, MD
Michael Steinmetz, MD (SUB_INVESTIGATOR)
Dominic Pelle, MD (PRINCIPAL_INVESTIGATOR)
Iain Kalfas, MD (SUB_INVESTIGATOR)

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By research site
IGEA· Union, NJAlbany Medical College· Albany, NYUniversity at Buffalo Neurosurgery· Williamsville, NYCleveland Clinic· Cleveland, OH

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