Axoguard HA Plus Nerve Protector to Reduce Post-operative Neck and Shoulder Dysfunction in Patients Undergoing Neck Dissection

NCT07283861 | Recruiting FDA Device

• 1 other identifier: STUDY25060040
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

shoulder function; neck dissection; head and neck cancer

Outcome Measures

Primary Outcomes (1)

• One year neck and shoulder dysfunction as assessed by the neck dissection impairment index

  The neck dissection impairment index is a score from 1-100 with 100 being a perfect score.

  one year

Study Arms (1)

Axoguard HA+ Arm

EXPERIMENTAL

Device: Spinal Accessory Nerve Protection utilizing Axoguard HA+

Interventions

Spinal Accessory Nerve Protection utilizing Axoguard HA+ DEVICE

Nerve protection utilizing a nerve wrap.

Axoguard HA+ Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Previously untreated malignancy of the head and neck including primary mucosal, cutaneous, salivary gland, and thyroid cancers
• Undergoing accessory-nerve sparing elective or therapeutic SND or MRND (involving level II and/or level V dissection)
• years or older
• Patients must give documented informed consent to participate in this study

You may not qualify if:

• Previous history of neck or shoulder surgery or radiation
• Inadvertent injury to or intentional sacrifice of the accessory nerve at time of neck dissection
• Medical contraindication to surgery under general anesthesia
• Known sensitivity to porcine materials
• Pregnant or lactating patients
• Incarcerated patients

Sponsors & Collaborators

• Matthew Spector: lead
• Axogen Corporation: collaborator

Study Sites (1)

UPMC Presbyterian Shadyside

Pittsburgh, Pennsylvania, 15213, United States

RECRUITING

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Study Officials

• Daniel Zandberg

  University of Pittsburgh

  STUDY CHAIR

Central Study Contacts

Matthew E Spector, MD

CONTACT

412-647-2100; spectorme@upmc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 6, 2025
• First Posted: December 16, 2025
• Study Start: December 9, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2028
• Last Updated: December 23, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: 12-1-25 to completion of study
• Access Criteria: Available upon request

Locations

US (1)