Axoguard HA Plus Nerve Protector to Reduce Post-operative Neck and Shoulder Dysfunction in Patients Undergoing Neck Dissection
NCT07283861 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 90
Last updated 2026-05-12
Summary
In this prospective study, patients with head and neck cancers undergoing neck dissection will have the nerve to the shoulder wrapped with the Axoguard HA+ Nerve Protector at time of surgery. In these patients, the presence and severity of neck and shoulder dysfunction on the operated side will be assessed approximately twelve months post-operatively. The investigators hypothesize that shoulder nerve wrapping with the Axoguard HA+ Nerve Protector will lead to clinically meaningful improvement of shoulder function.
Conditions
- Head and Neck Cancer
- Neck Dissection
Interventions
- DEVICE
-
Spinal Accessory Nerve Protection utilizing Axoguard HA+
Nerve protection utilizing a nerve wrap.
Sponsors & Collaborators
-
Axogen Corporation
collaborator INDUSTRY -
Matthew Spector
lead OTHER
Principal Investigators
-
Daniel Zandberg · University of Pittsburgh
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-12-09
- Primary Completion
- 2027-01-31
- Completion
- 2028-01-31
- FDA Device
- Yes
Countries
- United States
Study Locations
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