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NCT04865679 · ClinicalTrials.gov registry record · NA
Tolerability and Feasibility Pilot Clinical Study of a Large-Diameter Nerve Cap for Protecting and Preserving Terminated Nerve Ends
A NA study of Amputation and Symptomatic Neuroma, sponsored by Axogen Corporation.
- Active
- Registry status
- NA
- Development phase
- 15
- Enrollment target
- 2
- Study locations
NCT04865679: Active NA study of Amputation and Symptomatic Neuroma, sponsored by Axogen Corporation.
NCT04865679 is a NA study of Amputation and Symptomatic Neuroma that is active but no longer recruiting, run by Axogen Corporation. The registered enrollment target is 15 participants, below the 133-participant average among 65 other Amputation trials with a reported enrollment target (89% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04865679, a NA study of Amputation and Symptomatic Neuroma, is active but no longer recruiting, sponsored by Axogen Corporation.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 15 participants
- Enrollment target
- 2
- Study locations
Study Summary
This pilot study evaluates the tolerability and feasibility of the Axoguard Large-Diameter Nerve Cap (sizes 5-7 mm) for protecting and preserving terminated nerve endings after limb trauma or amputation when immediate attention to the nerve injuries is not possible.
Primary Outcome
The primary safety endpoint will monitor the nature and incidence of AE's, SAE's and/or UADE's associated with an unplanned revision procedure prior to the planned Targeted Muscle Reinnervation (TMR) or Regenerative Peripheral Nerve Interface (RPNI) starting from implantation (operative day) through 15 months depending on whether or not the subject undergoes the secondary TMR or RPNI procedure.
Conditions Studied
Interventions
- DEVICE Axoguard Nerve Cap®
Study Locations (2)
Massachusetts
- Massachusetts General Hospital - Boston
Texas
- Texas Tech University, Health Science Center - Lubbock
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2022-03-02 |
| Est. Completion | 2026-12 |
| Phase | NA |
What the registry record for NCT04865679 still lists
NCT04865679 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 133-participant average among 65 other Amputation trials with a reported enrollment target (89% lower).
The record links to 3 conditions, with Amputation appearing as the primary indexed condition, and to 1 intervention - of which Axoguard Nerve Cap® is the first listed.
NCT04865679 reports a single indexed study location in Massachusetts, Texas.
Frequently Asked Questions
What is clinical trial NCT04865679 about?
NCT04865679 is a clinical study titled "Tolerability and Feasibility Pilot Clinical Study of a Large-Diameter Nerve Cap for Protecting and Preserving Terminated Nerve Ends". This pilot study evaluates the tolerability and feasibility of the Axoguard Large-Diameter Nerve Cap (sizes 5-7 mm) for protecting and preserving terminated nerve endings after limb trauma or amputation when immediate attention to the nerve injuries is not possible.
What is the current status of trial NCT04865679?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 15 participants. The study started on 2022-03-02. Estimated completion is 2026-12.
What conditions does trial NCT04865679 study?
This clinical trial studies the following conditions: Amputation, Symptomatic Neuroma, Chronic Nerve Pain.
What interventions are being tested in trial NCT04865679?
The interventions under investigation include: Axoguard Nerve Cap® (DEVICE).
Who is sponsoring clinical trial NCT04865679?
This trial is sponsored by Axogen Corporation, which has 10 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04865679 being conducted?
This trial has 2 study locations across Massachusetts, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Amputation
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04865679's enrollment target sits among peer trials
15 44th of 65 higher than 20 of 65 other Amputation trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Amputation 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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