Head and Neck CancerNCT07283861
Axoguard HA Plus Nerve Protector to Reduce Post-operative Neck and Shoulder Dysfunction in Patients Undergoing Neck Dissection
A study testing Spinal Accessory Nerve Protection utilizing Axoguard HA+ in people with Head and Neck Cancer and Neck Dissection, run by Matthew Spector at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer, Neck Dissection
- What is being tested?
- Spinal Accessory Nerve Protection utilizing Axoguard HA+
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Dec 2025to Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
UPMC Presbyterian Shadyside
Pittsburgh, Pennsylvania, 15213
About this study
Official title: 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.
Read the 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.
- Conditions
- Head and Neck Cancer, Neck Dissection
- Being tested
- Spinal Accessory Nerve Protection utilizing Axoguard HA+
- Keywords
- shoulder function, neck dissection, head and neck cancer
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spinal Accessory Nerve Protection utilizing Axoguard HA+Device
Nerve protection utilizing a nerve wrap.
| Study group | Role | What they receive |
|---|---|---|
| Axoguard HA+ Arm | Experimental | Not described Receives: Device: Spinal Accessory Nerve Protection utilizing Axoguard HA+ |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2025
- Study start9 Dec 2025
- Primary completionJan 2027 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Matthew Spector
- Sponsor type
- University, hospital or other
- Collaborators
- Axogen Corporation
- Responsible party
- Sponsor-investigator, Matthew Spector, University of Pittsburgh
- Investigators
- Daniel Zandberg, Study chair, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07283861
- Sponsor's protocol ID
- STUDY25060040
- Status last verified
- May 2026
- First submitted
- 6 Dec 2025
- Last updated
- 12 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Available upon request
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07283861
- Acronym / sponsor ID
- STUDY25060040
- Conditions
- Head and Neck Cancer, Neck Dissection
- Keywords
- shoulder function, neck dissection, head and neck cancer
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Matthew SpectorUniversity, hospital or other
- Collaborators
- Axogen Corporation
- Study start
- 9 Dec 2025 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 16 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Axoguard HA+ Arm | Experimental | Device: Spinal Accessory Nerve Protection utilizing Axoguard HA+ |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Spinal Accessory Nerve Protection utilizing Axoguard HA+Nerve protection utilizing a nerve wrap. | Device | Axoguard HA+ Arm |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2026.
- Individual participant dataSharing planned: Yes. Available upon request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel Zandberg study chair
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spinal Accessory Nerve Protection utilizing Axoguard HA+ in people with Head and Neck Cancer and Neck Dissection, run by Matthew Spector at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 12 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
One year neck and shoulder dysfunction as assessed by the neck dissection impairment index (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2026.