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NCT03077204 · ClinicalTrials.gov registry record · Phase 4

BIO4 Clinical Case Study: Cervical Spine

A Phase 4 study, sponsored by Seton Healthcare Family.

Completed
Registry status
Phase 4
Development phase
20
Enrollment target

NCT03077204 is a Phase 4 study that has completed, run by Seton Healthcare Family. The registered enrollment target is 20 participants.

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The verdict

NCT03077204, a Phase 4 study, has completed, sponsored by Seton Healthcare Family.

COMPLETED
Registry status
Phase 4
Development phase
20 participants
Enrollment target

Study Summary

The goal of this study is to investigate the efficacy of BIO4 bone matrix in patients undergoing 1 or 2-level Anterior Cervical Discectomy and Fusion (ACDF) spine surgery. Specifically, the study aims to collect the data for ACDF model utilizing BIO4 with Bio AVS Cervical Allograft (with graft window).

Interventions

  • BIOLOGICAL 1 or 2-Level ACDF utilizing BIO4 with Bio AVS Cervical Allograft (with graft window).
  • DEVICE Aviator Anterior Cervical Plating System

Trial Details

FieldValue
Enrollment Target 20 participants
Start Date 2017-04-06
Est. Completion 2020-01-30
Phase Phase 4

Sponsor

Seton Healthcare Family

15 total trials

What the Registry Record Tells You About NCT03077204

The ClinicalTrials.gov registry entry for NCT03077204 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Seton Healthcare Family, which has 15 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which 1 or 2-Level ACDF utilizing BIO4 with Bio AVS Cervical Allograft (with graft window). is the first listed.

NCT03077204 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT03077204 about?

NCT03077204 is a clinical study titled "BIO4 Clinical Case Study: Cervical Spine". The goal of this study is to investigate the efficacy of BIO4 bone matrix in patients undergoing 1 or 2-level Anterior Cervical Discectomy and Fusion (ACDF) spine surgery. Specifically, the study aims to collect the data for ACDF model utilizing BIO4 with Bio AVS Cervical Allograft (with graft windo...

What is the current status of trial NCT03077204?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 20 participants. The study started on 2017-04-06. Estimated completion is 2020-01-30.

What interventions are being tested in trial NCT03077204?

The interventions under investigation include: 1 or 2-Level ACDF utilizing BIO4 with Bio AVS Cervical Allograft (with graft window). (BIOLOGICAL), Aviator Anterior Cervical Plating System (DEVICE).

Who is sponsoring clinical trial NCT03077204?

This trial is sponsored by Seton Healthcare Family, which has 15 total clinical trials registered on ClinicalTrials.gov.

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

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.