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Axoguard HA+ Nerve Protector for Neck Dissection

This study is looking at whether a device called Axoguard HA+ Nerve Protector can help reduce neck and shoulder problems after surgery for head and neck cancer. If you have head and neck cancer and are having a neck dissection (a surgery to remove lymph nodes in the neck), you might be able to join. During your surgery, the Axoguard HA+ Nerve Protector will be wrapped around the spinal accessory nerve (a nerve that controls shoulder movement). Researchers will then check your neck and shoulder function about one year after surgery. The goal is to see if using this nerve protector leads to better shoulder function compared to what is usually seen.

Study design
This is an interventional study planning to enroll 90 participants. All participants will receive the Axoguard HA+ Nerve Protector during their surgery.
What's involved
You will undergo a neck dissection surgery where the Axoguard HA+ Nerve Protector is applied. Your neck and shoulder function will be assessed before surgery and again one year after surgery.
Compensation
Not stated in the trial record.
Follow-up
Your neck and shoulder function will be assessed approximately twelve months after surgery.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07283861

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

Active, Not Recruiting
NAAges 18+InterventionalTreatment
Matthew Spector
~90 participants
Updated 2026-05-12 on ClinicalTrials.gov
What's tested:Spinal Accessory Nerve Protection utilizing Axoguard HA+

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
One year neck and shoulder dysfunction as assessed by the neck dissection impairment index
Measured over one year

Conditions

Head and Neck Cancer
Neck Dissection

Explore related trials

Malignant Head and Neck Neoplasm

Where it's being run

1 sites across 1 states
Pennsylvania1

Study leadership

  • Daniel Zandberg · STUDY_CHAIR · University of Pittsburgh

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

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

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