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NCT04564885 · ClinicalTrials.gov registry record · NA
A Clinical Trial Comparing the BAGUERA C to the Marketed Mobi-C® for the Treatment of Cervical Disc Disease at 2 Contiguous Levels
A NA study of Cervical Disc Disease, sponsored by Spineart U.
- Active
- Registry status
- NA
- Development phase
- 300
- Enrollment target
- 20
- Study locations
NCT04564885: Active NA study of Cervical Disc Disease, sponsored by Spineart U.
NCT04564885 is a NA study of Cervical Disc Disease that is active but no longer recruiting, run by Spineart U. The registered enrollment target is 300 participants, above the 122-participant average among 3 other Cervical Disc Disease trials with a reported enrollment target (146% higher). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04564885, a NA study of Cervical Disc Disease, is active but no longer recruiting, sponsored by Spineart U.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 300 participants
- Enrollment target
- 20
- Study locations
Study Summary
The proposed investigation is a multi-center, prospective, randomized, controlled comparison of the BAGUERA®C to the control, a similar, legally marketed total disc replacement device in subjects with symptomatic cervical disc disease (SCDD) at two contiguous levels. Subjects will be randomized in a 2:1 ratio to the two-level BAGUERA®C Cervical Disc Prosthesis (investigational group) or to the two-level Mobi-C® Cervical Disc (control group). Subjects enrolled in the study will be evaluated pre-operatively, at the time of surgery, discharge, and at 6 weeks, 3, 6, 12, and 24 months and then annually until 7 years post-surgery.
Primary Outcome
at least a 15 percentage point improvement (decrease) from baseline on a 0 - 100% scale
Conditions Studied
Interventions
- DEVICE Mobi-C Cervical Disc
- DEVICE BAGUERA®C Cervical Disc Prosthesis
Study Locations (20)
California
- BEEL Medical - Laguna Hills
- Orange County Neurosurgical Associates - Mission Viejo
- UCI Health - Orange
- Eisenhower Medical Center - Rancho Mirage
- The Spine Institute, Center for Spine Restoration - Santa Monica
- Institute for Neuro Innovation - West Hills
Arizona
- MORE Foundation - Phoenix
- Desert Institute for Spine Care - Scottsdale
Illinois
- Midwest Orthopedics at Rush - Chicago
- NorthShore - Evanston
Indiana
- Indiana Spine Group - Carmel
- Ortho NorthEast - Fort Wayne
Colorado
- Vail-Summit Orthopaedics and Neurosurgery - Vail
Connecticut
- Hartford Health CT Orthopaedics - Hamden
District of Columbia
- Georgetown University Medical Center - Washington D.C.
Georgia
- Legacy Brain & Spine - Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 300 participants |
| Start Date | 2021-03-02 |
| Est. Completion | 2030-04 |
| Phase | NA |
What the registry record for NCT04564885 still lists
NCT04564885 is an interventional study that assigns participants to a tested intervention. The registered 300 participants enrollment target is mid-sized for trials with a published cap, above the 122-participant average among 3 other Cervical Disc Disease trials with a reported enrollment target (146% higher).
The record links to 1 condition, with Cervical Disc Disease appearing as the primary indexed condition, and to 2 interventions - of which Mobi-C Cervical Disc is the first listed.
NCT04564885 names 20 study sites across 12 states, led by California, Arizona, Illinois.
Frequently Asked Questions
What is clinical trial NCT04564885 about?
NCT04564885 is a clinical study titled "A Clinical Trial Comparing the BAGUERA C to the Marketed Mobi-C® for the Treatment of Cervical Disc Disease at 2 Contiguous Levels". The proposed investigation is a multi-center, prospective, randomized, controlled comparison of the BAGUERA®C to the control, a similar, legally marketed total disc replacement device in subjects with symptomatic cervical disc disease (SCDD) at two contiguous levels. Subjects will be randomized in a...
What is the current status of trial NCT04564885?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 300 participants. The study started on 2021-03-02. Estimated completion is 2030-04.
What conditions does trial NCT04564885 study?
This clinical trial studies the following conditions: Cervical Disc Disease.
What interventions are being tested in trial NCT04564885?
The interventions under investigation include: Mobi-C Cervical Disc (DEVICE), BAGUERA®C Cervical Disc Prosthesis (DEVICE).
Who is sponsoring clinical trial NCT04564885?
This trial is sponsored by Spineart U, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04564885 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Connecticut, District of Columbia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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