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NCT01809002 · ClinicalTrials.gov registry record · Phase 3
Comparison of Processed Nerve Allograft and Collagen Nerve Cuffs for Peripheral Nerve Repair
A Phase 3 study, sponsored by Axogen Corporation.
- Completed
- Registry status
- Phase 3
- Development phase
- 220
- Enrollment target
NCT01809002: Completed Phase 3 study, sponsored by Axogen Corporation.
NCT01809002 is a Phase 3 study that has completed, run by Axogen Corporation. The registered enrollment target is 220 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (72% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01809002, a Phase 3 study, has completed, sponsored by Axogen Corporation.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 220 participants
- Enrollment target
Study Summary
Processed Nerve Allograft and Collagen Nerve Cuffs will be compared to assess safety and functional outcomes for the repair of nerve injuries in the hand.
Primary Outcome
Static two-point discrimination (s2PD) is measured by a blinded assessor using a standardized discriminator tool that measures the innervation density and the subject's ability to discern between a single point and two distinct points between 2mm (best case scenario value possible) and 15mm. The failure to respond to stimulus was pre-defined as the worst case scenario value possible (16mm). Missing or incomplete assessments were imputed as the worst case scenario value possible (16mm). Missing o
Interventions
- BIOLOGICAL Processed Nerve Allograft (human)
- DEVICE Collagen Nerve Cuff
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 220 participants |
| Start Date | 2015-06 |
| Est. Completion | 2021-08-30 |
| Phase | Phase 3 |
What the finished NCT01809002 record still lists
NCT01809002 is an interventional study that assigns participants to a tested intervention. The registered 220 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (72% lower).
The record links to 0 conditions, and to 2 interventions - of which Processed Nerve Allograft (human) is the first listed.
NCT01809002 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01809002 about?
NCT01809002 is a clinical study titled "Comparison of Processed Nerve Allograft and Collagen Nerve Cuffs for Peripheral Nerve Repair". Processed Nerve Allograft and Collagen Nerve Cuffs will be compared to assess safety and functional outcomes for the repair of nerve injuries in the hand.
What is the current status of trial NCT01809002?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 220 participants. The study started on 2015-06. Estimated completion is 2021-08-30.
What interventions are being tested in trial NCT01809002?
The interventions under investigation include: Processed Nerve Allograft (human) (BIOLOGICAL), Collagen Nerve Cuff (DEVICE).
Who is sponsoring clinical trial NCT01809002?
This trial is sponsored by Axogen Corporation, which has 10 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01809002's enrollment target sits among peer trials
220 1318th of 2000 higher than 672 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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