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ACTIVE NOT RECRUITING NA

A Clinical Trial Comparing the BAGUERA C to the Marketed Mobi-C® for the Treatment of Cervical Disc Disease at 2 Contiguous Levels

NCT04564885 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 300 participants
Start Date 2021-03-02
Est. Completion 2030-04
Phase NA

Sponsor

Spineart U

1 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04564885

The ClinicalTrials.gov registry entry for NCT04564885 describes a study currently listed as active not recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 300 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Spineart U, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04564885 reports 20 study locations spanning 12 distinct geographic areas — top geographies include California, Arizona, Illinois. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04564885?

The interventions under investigation include: Mobi-C Cervical Disc (DEVICE), BAGUERA®C Cervical Disc Prosthesis (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04564885?

This trial is sponsored by Spineart U, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial