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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 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. The trial reports 7 study locations across 7 states.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06117501
The ClinicalTrials.gov registry entry for NCT06117501 describes a study currently listed as active not recruiting, categorized as NA. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Axogen Corporation, which has 10 total studies on file at ClinicalTrials.gov.
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 reports 7 study locations spanning 7 distinct geographic areas - top geographies include 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.
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Recurrent Cubital Tunnel Syndrome
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Recalcitrant Cubital Tunnel Syndrome
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Florida
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