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Active Not RecruitingNCT04865679

Tolerability and Feasibility Pilot Clinical Study of a Large-Diameter Nerve Cap for Protecting and Preserving Terminated Nerve Ends

Status
Active Not Recruiting
Phase
N/A
Study type
Interventional
Enrollment
15 (estimated)
Sponsor
Axogen Corporation · Industry
Sex
All
Age
18 Years – 80 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DEVICEAxoguard Nerve Cap®Entubulation of the nerve stump into the Axoguard Nerve Cap® following surgical excision of symptomatic neuroma

Timeline

Start date
2022-03-02
Primary completion
2026-12-01
Completion
2026-12-01
First posted
2021-04-29
Last updated
2025-05-02

Locations

2 sites across 1 country: United States

Regulatory

Source: ClinicalTrials.gov record NCT04865679. Inclusion in this directory is not an endorsement.

Tolerability and Feasibility Pilot Clinical Study of a Large-Diameter Nerve Cap for Protecting and Preserving Terminated (NCT04865679) · Clinical Trials Directory