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

Primary Purpose

Neck Pain, Spondylosis, Spondylosis With Myelopathy

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CEM-Plate Anterior Cervical Plating System and CEM-Cage Cervical Interbody System
Sponsored by
ReVivo Medical, Corp.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neck Pain focused on measuring Cervical Spondylosis, Cervical Myelopathy, Cervical Radiculopathy, Neck Pain

Eligibility Criteria

22 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Males and females aged 22-79 years.
  2. Documented diagnosis of cervical spine radiculopathy or myelopathy.
  3. Symptomatic cervical degenerative disc disease at 2 contiguous levels between C2 through T1.
  4. Baseline NDI score ≥30 and/or baseline mJOA score ≤16.
  5. Pathology at the level to be treated correlating to the primary symptoms confirmed by imaging (computed tomography (CT), CT myelography, magnetic resonance imaging (MRI), or plain radiography).
  6. Unresponsive to non-operative, conservative treatment for at least 6 weeks from symptom onset or presence of progressive cervical myelopathy or signs of nerve root/spinal cord compression despite continued non-operative treatment.
  7. Ability to speak, read, and understand the IRB approved Informed Consent document.
  8. Willingness to give informed consent for participation in the study.

Exclusion Criteria:

  1. Any prior cervical surgeries at the symptomatic levels; prior surgery or cervical fusion procedure at any level.
  2. Fewer than 2 or more than 2 vertebral levels requiring treatment.
  3. Anatomy that is non-conducive to receiving investigational device.
  4. More than one immobile vertebral level between C-1 to C-7 from any cause, including but not limited to congenital abnormalities and osteoarthritic "spontaneous" fusions.
  5. Known diagnosis of osteoporosis, current pharmacological treatment for osteoporosis or bone density which in the medical opinion of the surgeon precludes operation or contraindicates instrumentation.
  6. Paget disease, osteomalacia, or any other metabolic bone disease other than osteoporosis.
  7. Active malignancy that includes a history of any invasive malignancy (except nonmelanoma skin cancer), unless previously treated with curative intent and with no clinical signs or symptoms of the malignancy for > 5 years.
  8. Severe cervical instability based on radiographic exam (whereby an anterior and posterior reconstructive procedure is indicated).
  9. Decompression requiring corpectomy at one or more levels.
  10. Active systemic infection or an infection localized to the site of the proposed implantation.
  11. Open wounds.
  12. Signs of local inflammation.
  13. Fever.
  14. Any diseases or conditions that would preclude accurate clinical evaluation.
  15. Daily, high-dose oral and/or inhaled steroids or a history of chronic use of high-dose steroids.
  16. BMI > 40.
  17. Use of any other investigational drug or medical device within 30 days prior to surgery.
  18. Smoking more than 1 pack of cigarettes/day.
  19. Mental illness that, in the opinion of the investigator, would preclude patient's ability to participate in the study.
  20. Current or recent history of substance abuse (alcoholism and/or narcotic addiction) requiring intervention.
  21. Litigation relating to spinal injury/worker's compensation.
  22. Reported to have a history of or anticipated treatment for active systemic infection, including human immunodeficiency virus (HIV) or Hepatitis C.
  23. Previous trauma to the C2 to T1 levels resulting in significant bony or disco-ligamentous cervical spine injury.
  24. Axial neck pain in the absence of other symptoms of radiculopathy or myeloradiculopathy or myelopathy justifying the need for surgical intervention.
  25. Pregnancy.
  26. Any medical or surgical condition which would preclude the potential benefit of spinal implant surgery, such as the elevation of sedimentation rate unexplained by other diseases, elevation of white blood count (WBC), or a marked left shift in the WBC differential count.
  27. Suspected or documented metal allergy or intolerance.
  28. Inadequate tissue coverage over the operative site or where there is inadequate bone stock, bone quality, or anatomical definition.
  29. Any patient unwilling to cooperate with the post-operative instructions.
  30. Any time implant utilization would interfere with anatomical structures or expected physiological performance.

Sites / Locations

  • IGEARecruiting
  • Albany Medical CollegeRecruiting
  • Cleveland ClinicRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment

Arm Description

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

Outcomes

Primary Outcome Measures

Fusion
Flexion-extension plain radiographs will be used to assess bony fusion at both surgical levels.

Secondary Outcome Measures

Device-Related Adverse Events
No serious adverse events related to the surgical procedure, no device-related serious adverse events, no subsequent surgical interventions at the index levels, and absence of clinically significant device malfunctions.

Full Information

First Posted
May 5, 2021
Last Updated
July 17, 2023
Sponsor
ReVivo Medical, Corp.
Collaborators
Albany Medical College, The Cleveland Clinic, IGEA
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1. Study Identification

Unique Protocol Identification Number
NCT04883411
Brief Title
CEM-Plate and CEM-Cage First-In-Human Use Efficacy Study
Official Title
First-in-human Prospective Study to Assess the Safety and Efficacy of the CEM-Cage and CEM-Plate
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 7, 2022 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
June 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ReVivo Medical, Corp.
Collaborators
Albany Medical College, The Cleveland Clinic, IGEA

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
Detailed Description
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. The study consists of a screening period, surgical procedure, and 6 post-operative visits. At each indicated visit, quality of life scales and adverse events will be collected. In addition, at 4 weeks post-operatively, patients will undergo static lateral cervical plain x rays to assess implant positioning and integrity. At 3 months, 6 months, 12 months, 18 months, and 24 months, patients will undergo flexion/extension and neutral lateral plain radiographs to assess overall success and fusion. The study has co-primary endpoints for efficacy (fusion) and overall success where overall success is defined as fusion, device implanted as intended, no serious adverse events related to the surgical procedure, no device-related serious adverse events, no subsequent surgical interventions at the index levels, and absence of clinically significant device malfunctions. Fusion data will be compared to benchmark data (Davis et al, 2013, control arm of the 2-level Mobi-C IDE study).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neck Pain, Spondylosis, Spondylosis With Myelopathy, Spondylosis With Radiculopathy, Spondylosis With Radiculopathy Cervical Region, Intervertebral Disc Disorder Cervical
Keywords
Cervical Spondylosis, Cervical Myelopathy, Cervical Radiculopathy, Neck Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Prospective, first-in-human, multi-center, non-randomized, single arm study.
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment
Arm Type
Experimental
Arm Description
Two-Level ACDF with CEM-Plate Anterior Cervical Plating System and CEM-Cage Cervical Interbody System.
Intervention Type
Device
Intervention Name(s)
CEM-Plate Anterior Cervical Plating System and CEM-Cage Cervical Interbody System
Intervention Description
Two-Level ACDF with CEM-Plate Anterior Cervical Plating System and CEM-Cage Cervical Interbody System
Primary Outcome Measure Information:
Title
Fusion
Description
Flexion-extension plain radiographs will be used to assess bony fusion at both surgical levels.
Time Frame
24 months.
Secondary Outcome Measure Information:
Title
Device-Related Adverse Events
Description
No serious adverse events related to the surgical procedure, no device-related serious adverse events, no subsequent surgical interventions at the index levels, and absence of clinically significant device malfunctions.
Time Frame
24 months.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
22 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Males and females aged 22-79 years. Documented diagnosis of cervical spine radiculopathy or myelopathy. Symptomatic cervical degenerative disc disease at 2 contiguous levels between C2 through T1. Baseline NDI score ≥30 and/or baseline mJOA score ≤16. Pathology at the level to be treated correlating to the primary symptoms confirmed by imaging (computed tomography (CT), CT myelography, magnetic resonance imaging (MRI), or plain radiography). Unresponsive to non-operative, conservative treatment for at least 6 weeks from symptom onset or presence of progressive cervical myelopathy or signs of nerve root/spinal cord compression despite continued non-operative treatment. Ability to speak, read, and understand the IRB approved Informed Consent document. Willingness to give informed consent for participation in the study. Exclusion Criteria: Any prior cervical surgeries at the symptomatic levels; prior surgery or cervical fusion procedure at any level. Fewer than 2 or more than 2 vertebral levels requiring treatment. Anatomy that is non-conducive to receiving investigational device. More than one immobile vertebral level between C-1 to C-7 from any cause, including but not limited to congenital abnormalities and osteoarthritic "spontaneous" fusions. Known diagnosis of osteoporosis, current pharmacological treatment for osteoporosis or bone density which in the medical opinion of the surgeon precludes operation or contraindicates instrumentation. Paget disease, osteomalacia, or any other metabolic bone disease other than osteoporosis. Active malignancy that includes a history of any invasive malignancy (except nonmelanoma skin cancer), unless previously treated with curative intent and with no clinical signs or symptoms of the malignancy for > 5 years. Severe cervical instability based on radiographic exam (whereby an anterior and posterior reconstructive procedure is indicated). Decompression requiring corpectomy at one or more levels. Active systemic infection or an infection localized to the site of the proposed implantation. Open wounds. Signs of local inflammation. Fever. Any diseases or conditions that would preclude accurate clinical evaluation. Daily, high-dose oral and/or inhaled steroids or a history of chronic use of high-dose steroids. BMI > 40. Use of any other investigational drug or medical device within 30 days prior to surgery. Smoking more than 1 pack of cigarettes/day. Mental illness that, in the opinion of the investigator, would preclude patient's ability to participate in the study. Current or recent history of substance abuse (alcoholism and/or narcotic addiction) requiring intervention. Litigation relating to spinal injury/worker's compensation. Reported to have a history of or anticipated treatment for active systemic infection, including human immunodeficiency virus (HIV) or Hepatitis C. Previous trauma to the C2 to T1 levels resulting in significant bony or disco-ligamentous cervical spine injury. Axial neck pain in the absence of other symptoms of radiculopathy or myeloradiculopathy or myelopathy justifying the need for surgical intervention. Pregnancy. Any medical or surgical condition which would preclude the potential benefit of spinal implant surgery, such as the elevation of sedimentation rate unexplained by other diseases, elevation of white blood count (WBC), or a marked left shift in the WBC differential count. Suspected or documented metal allergy or intolerance. Inadequate tissue coverage over the operative site or where there is inadequate bone stock, bone quality, or anatomical definition. Any patient unwilling to cooperate with the post-operative instructions. Any time implant utilization would interfere with anatomical structures or expected physiological performance.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eric H Ledet, Ph.D.
Phone
5182270743
Email
eledet@revivomedical.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John German, MD
Organizational Affiliation
Albany Medical College
Official's Role
Principal Investigator
Facility Information:
Facility Name
IGEA
City
Union
State/Province
New Jersey
ZIP/Postal Code
07083
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Adam Lipson, MD
First Name & Middle Initial & Last Name & Degree
Adam Lipson, MD
Facility Name
Albany Medical College
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
John German, MD
First Name & Middle Initial & Last Name & Degree
Darryl DiRisio, MD
First Name & Middle Initial & Last Name & Degree
Robert Cheney, MD
First Name & Middle Initial & Last Name & Degree
John German, MD
First Name & Middle Initial & Last Name & Degree
John Dalfino, MD
First Name & Middle Initial & Last Name & Degree
Frank Genovese, MD
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dominic Pelle, MD
First Name & Middle Initial & Last Name & Degree
Michael Steinmetz, MD
First Name & Middle Initial & Last Name & Degree
Dominic Pelle, MD
First Name & Middle Initial & Last Name & Degree
Iain Kalfas, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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

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