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NCT06117501 · ClinicalTrials.gov registry record · NA
Nerve Protection Evaluation: Revision Cubital Tunnel Syndrome Decompression
A NA study of Recurrent Cubital Tunnel Syndrome and Recalcitrant Cubital Tunnel Syndrome, sponsored by Axogen Corporation.
- Active
- Registry status
- NA
- Development phase
- 20
- Enrollment target
- 7
- Study locations
NCT06117501: Active NA study of Recurrent Cubital Tunnel Syndrome and Recalcitrant Cubital Tunnel Syndrome, sponsored by Axogen Corporation.
NCT06117501 is a NA study of Recurrent Cubital Tunnel Syndrome and Recalcitrant Cubital Tunnel Syndrome that is active but no longer recruiting, run by Axogen Corporation. The registered enrollment target is 20 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). The trial reports 7 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06117501, a NA study of Recurrent Cubital Tunnel Syndrome and Recalcitrant Cubital Tunnel Syndrome, is active but no longer recruiting, sponsored by Axogen Corporation.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 20 participants
- Enrollment target
- 7
- Study locations
Study Summary
This single-cohort, prospective case series is designed to evaluate and characterize the use of Axoguard HA+ Nerve Protector™ to protect the ulnar nerve in a first revision cubital tunnel decompression procedure. Data on the primary cubital tunnel syndrome decompression, first revision decompression utilizing Axoguard HA+ Nerve Protector, participant-reported pain, motor and sensory functional outcomes, quality of life (QoL) outcomes, and recurrence/revision will be collected. This case series will help to establish the ability of Axoguard HA+ Nerve Protector to provide clinical benefits for patients undergoing a first revision cubital tunnel decompression procedure.
Primary Outcome
Change from baseline in visual analog scale (VAS) pain scores (0-100 mm) will be evaluated between post-operative months 6 to 18 to characterize treatment response over time.
Conditions Studied
Interventions
- DEVICE Axoguard HA+ Nerve Protector™
Study Locations (7)
Florida
- Foundation for Orthopaedic Research and Education (Florida Orthopaedic Institute) - Tampa
Georgia
- Optim Orthopedics - Savannah
Indiana
- Indiana Hand to Shoulder Center - Indianapolis
New Mexico
- University of New Mexico - Albuquerque
Ohio
- Cleveland Clinic - Cleveland
Pennsylvania
- Rothman Orthopaedics - Philadelphia
Utah
- University of Utah - Salt Lake City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2023-10-19 |
| Est. Completion | 2026-12 |
| Phase | NA |
What the registry record for NCT06117501 still lists
NCT06117501 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 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 2 conditions, with Recurrent Cubital Tunnel Syndrome appearing as the primary indexed condition, and to 1 intervention - of which Axoguard HA+ Nerve Protector™ is the first listed.
NCT06117501 lists 7 locations in 7 states (Florida, Georgia, Indiana).
Frequently Asked Questions
What is clinical trial NCT06117501 about?
NCT06117501 is a clinical study titled "Nerve Protection Evaluation: Revision Cubital Tunnel Syndrome Decompression". This single-cohort, prospective case series is designed to evaluate and characterize the use of Axoguard HA+ Nerve Protector™ to protect the ulnar nerve in a first revision cubital tunnel decompression procedure. Data on the primary cubital tunnel syndrome decompression, first revision decompression...
What is the current status of trial NCT06117501?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 20 participants. The study started on 2023-10-19. Estimated completion is 2026-12.
What conditions does trial NCT06117501 study?
This clinical trial studies the following conditions: Recurrent Cubital Tunnel Syndrome, Recalcitrant Cubital Tunnel Syndrome.
What interventions are being tested in trial NCT06117501?
The interventions under investigation include: Axoguard HA+ Nerve Protector™ (DEVICE).
Who is sponsoring clinical trial NCT06117501?
This trial is sponsored by Axogen Corporation, which has 10 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06117501 being conducted?
This trial has 7 study locations across Florida, Georgia, Indiana, New Mexico, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06117501's enrollment target sits among peer trials
20 1768th of 2000 higher than 140 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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