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

NCT ID: NCT07283861

Last Updated: 2025-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-09

Study Completion Date

2028-01-31

Brief Summary

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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

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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.

Conditions

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Neck Dissection Head and Neck Cancer

Keywords

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shoulder function neck dissection head and neck cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Axoguard HA+ Arm

Group Type EXPERIMENTAL

Spinal Accessory Nerve Protection utilizing Axoguard HA+

Intervention Type DEVICE

Nerve protection utilizing a nerve wrap.

Interventions

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Spinal Accessory Nerve Protection utilizing Axoguard HA+

Nerve protection utilizing a nerve wrap.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Axogen Corporation

INDUSTRY

Sponsor Role collaborator

Matthew Spector

OTHER

Sponsor Role lead

Responsible Party

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Matthew Spector

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Daniel Zandberg

Role: STUDY_CHAIR

University of Pittsburgh

Locations

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UPMC Presbyterian Shadyside

Pittsburgh, Pennsylvania, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Matthew E Spector, MD

Role: CONTACT

Phone: 412-647-2100

Email: [email protected]

Facility Contacts

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Matthew E Spector, MD

Role: primary

Other Identifiers

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STUDY25060040

Identifier Type: -

Identifier Source: org_study_id