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

May 10, 2026 updated by: Matthew Spector

A Phase 2 Trial of Accessory Nerve Wrapping With the Axoguard HA Plus Nerve Protector to Reduce Post-operative Neck and Shoulder Dysfunction in Patients Undergoing Neck Dissection

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

All patients will undergo neck dissection and the spinal accessory nerve wrapped with the Axoguard HA+ Nerve Protector. The Neck Dissection Impairment Index will be administered before surgery and 1 year after surgery and compared to historical controls. The NDII is on a 100 point scale with a higher score indicating a better shoulder function.

Study Type

Interventional

Enrollment (Estimated)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • UPMC Presbyterian Shadyside

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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)
  • 18 years or older
  • Patients must give documented informed consent to participate in this study

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Axoguard HA+ Arm
Device: Spinal Accessory Nerve Protection utilizing Axoguard HA+
Nerve protection utilizing a nerve wrap.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
One year neck and shoulder dysfunction as assessed by the neck dissection impairment index
Time Frame: one year
The neck dissection impairment index is a score from 1-100 with 100 being a perfect score.
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Matthew Spector

Collaborators

Axogen Corporation

Investigators

  • Study Chair: Daniel Zandberg, University of Pittsburgh

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 9, 2025

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

January 1, 2028

Study Registration Dates

First Submitted

December 6, 2025

First Submitted That Met QC Criteria

December 6, 2025

First Posted (Actual)

December 16, 2025

Study Record Updates

Last Update Posted (Actual)

May 12, 2026

Last Update Submitted That Met QC Criteria

May 10, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY25060040

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Available upon request

IPD Sharing Time Frame

12-1-25 to completion of study

IPD Sharing Access Criteria

Available upon request

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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