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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07283861

Enrollment

Registered

2025-12-16

Start date

2025-12-09

Completion date

2028-01-01

Last updated

2026-05-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Head and Neck Cancer, Neck Dissection

Keywords

shoulder function, neck dissection, head and neck cancer

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.

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.

Interventions

DEVICESpinal Accessory Nerve Protection utilizing Axoguard HA+

Nerve protection utilizing a nerve wrap.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Countries

United States

Contacts

STUDY_CHAIRDaniel Zandberg

University of Pittsburgh

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 13, 2026