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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: Completed Phase 4 study, sponsored by Seton Healthcare Family.
NCT03077204 is a Phase 4 study that has completed, run by Seton Healthcare Family. The registered enrollment target is 20 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
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).
Primary Outcome
This will be used to monitor the fusion status at 1 year post-op. The fusion states was reported as the number of patients who fused. If fused, then we say "Yes". We counted the number of patients who fused. If all 20 patients fused then we said there were 20 "yes".
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
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2017-04-06 |
| Est. Completion | 2020-01-30 |
| Phase | Phase 4 |
What the finished NCT03077204 record still lists
NCT03077204 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (96% lower).
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 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03077204's enrollment target sits among peer trials
20 1753rd of 2000 higher than 167 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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