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NCT04416321 · ClinicalTrials.gov registry record · NA
A Clinical Study to Evaluate Safety and Performance of PEEK-OPTIMA™ HA Enhanced.
A NA study, sponsored by Invibio.
- Completed
- Registry status
- NA
- Development phase
- 25
- Enrollment target
NCT04416321: Completed NA study, sponsored by Invibio.
NCT04416321 is a NA study that has completed, run by Invibio. The registered enrollment target is 25 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04416321, a NA study, has completed, sponsored by Invibio.
- COMPLETED
- Registry status
- NA
- Development phase
- 25 participants
- Enrollment target
Study Summary
The purpose of this trial is to collect clinical outcomes including radiographic and CT outcomes in patients who undergo spinal fusion using the Keos Lumbar Interbody Fusion Device.
Primary Outcome
Interbody fusion will be graded along the superior and inferior interfaces separately in 25% increments
Interventions
- DEVICE Surgery with the Keos Lumbar Interbody Fusion Device
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2021-07-01 |
| Est. Completion | 2026-01-27 |
| Phase | NA |
What the finished NCT04416321 record still lists
NCT04416321 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 1 intervention - of which Surgery with the Keos Lumbar Interbody Fusion Device is the first listed.
NCT04416321 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04416321 about?
NCT04416321 is a clinical study titled "A Clinical Study to Evaluate Safety and Performance of PEEK-OPTIMA™ HA Enhanced.". The purpose of this trial is to collect clinical outcomes including radiographic and CT outcomes in patients who undergo spinal fusion using the Keos Lumbar Interbody Fusion Device.
What is the current status of trial NCT04416321?
This trial is currently completed. It is a NA study. The enrollment target is 25 participants. The study started on 2021-07-01. Estimated completion is 2026-01-27.
What interventions are being tested in trial NCT04416321?
The interventions under investigation include: Surgery with the Keos Lumbar Interbody Fusion Device (DEVICE).
Who is sponsoring clinical trial NCT04416321?
This trial is sponsored by Invibio, which has 4 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04416321's enrollment target sits among peer trials
25 1712th of 2000 higher than 265 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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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