Head and Neck CancerNCT07268092
Porcine Extracellular Matrix Nerve Wrap in Neck Dissection for Head and Neck Cancer
A study testing Porcine Extracellular Matrix Nerve Wrap (AxoGuard Nerve Protector™) in people with Head and Neck Cancer and Neck Dissection, run by Henry Ford Health System at 1 site in United States.
Trial summary
Perform a preliminary efficacy study using the porcine extracellular matrix nerve wrap (AxoGuard Nerve Protector™, AxoGen Inc., Alachua, FL) to wrap the spinal accessory nerve (SAN) during neck dissections for head and neck cancer as it relates to postoperative shoulder function, both subjectively and objectively. 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, Postoperative Complications
- What is being tested?
- Porcine Extracellular Matrix Nerve Wrap (AxoGuard Nerve Protector™)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Jan 2021to 12 Aug 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Patients at least 18 years old
- Patients with no previous treatment of head and neck cancer
- Patients with no prior neck surgeries
- Patients undergoing level IIA and IIB neck diss
Who cannot join
- Patients with previously treated head and neck cancers
- Patients undergoing level V neck dissection
- Patients undergoing bilateral neck dissection
- Patients with previous neck surgery unrelated to head and neck cancer
- Patients allergic to porcine products or with religious/cultural restrictions on porcine products
- Patients unable to consent
Show all 9Show fewer
- Individuals who are not adults (infants, children, teenagers)
- Pregnant women
- Prisoners
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Porcine Extracellular Matrix Nerve Wrap on Spinal Accessory Nerve in Patients Undergoing Neck Dissection for Head and Neck Cancer
Perform a preliminary efficacy study using the porcine extracellular matrix nerve wrap (AxoGuard Nerve Protector™, AxoGen Inc., Alachua, FL) to wrap the spinal accessory nerve (SAN) during neck dissections for head and neck cancer as it relates to postoperative shoulder function, both subjectively and objectively.
Read the detailed description
Many patients who have surgery for head and neck cancer also need a procedure called a neck dissection, where lymph nodes and tissue are removed from the neck. During this surgery, even when a nerve called the spinal accessory nerve (SAN) is carefully preserved, patients often have shoulder problems afterward. These problems can include pain, weakness, and difficulty lifting the arm, which can affect daily activities and quality of life.
This study is testing whether using a special nerve wrap made from pig tissue (called AxoGuard® Nerve Protector) can help protect the spinal accessory nerve during surgery and improve shoulder movement and strength after surgery. This nerve wrap is already used in other types of nerve surgeries and may help the nerve heal better by reducing scar tissue and irritation.
- Being tested
- Porcine Extracellular Matrix Nerve Wrap (AxoGuard Nerve Protector™)
- Keywords
- Spinal Accessory Nerve Injury, Shoulder Dysfunction, Head and Neck Cancer, Nerve Compression Syndromes, Postoperative Complications
- Medical subject headings
- Head and Neck Neoplasms, Postoperative Complications, Accessory Nerve Injuries, Nerve Compression Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Porcine Extracellular Matrix Nerve Wrap (AxoGuard Nerve Protector™)Device
The intervention involves the application of the AxoGuard Nerve Protector™, a nerve wrap derived from porcine extracellular matrix (ECM), to the spinal accessory nerve (SAN) during neck dissection surgery in head and neck cancer patients. The device is designed to protect and support the nerve by preserving the extracellular matrix and creating a favorable environment for nerve healing. This helps prevent inflammation and fibrosis around the nerve, potentially improving postoperative shoulder function. The nerve wrap is applied intraoperatively after dissection but before surgical closure. The study compares this intervention to standard neck dissection without nerve wrapping.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm - Neck dissection with AxoGuard Nerve Protector™ | Experimental | Participants undergo neck dissection surgery for head and neck cancer, during which the spinal accessory nerve (SAN) is wrapped with the AxoGuard Nerve Protector™ (porcine extracellular matrix nerve wrap). This intervention aims to improve postoperative shoulder function by protecting and supporting the nerve during healing. Postoperative physical therapy evaluations will be conducted at baseline, immediate post-op, 1, 6, and 12 months. Receives: Device: Porcine Extracellular Matrix Nerve Wrap (AxoGuard Nerve Protector™) |
| Control Arm - Neck dissection without AxoGuard Nerve Protector™. | No intervention | Participants undergo standard neck dissection surgery for head and neck cancer without the application of the AxoGuard Nerve Protector™. Postoperative physical therapy evaluations will be conducted at baseline, immediate post-op, 1, 6, and 12 months to assess shoulder function. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in shoulder flexion active range of motion (degrees)
Shoulder flexion active range of motion will be measured using goniometry. A clinically significant decline is defined as a ≥12° decrease compared to preoperative baseline.
Unit of Measure: Degrees
Measured: From preoperative baseline assessment up to 12 months post-surgery
Change from baseline in Quick Disabilities of the Arm, Shoulder, and Hand (QuickDASH) score
Subjective upper extremity function will be assessed using the QuickDASH questionnaire (0-100 scale, higher scores indicate worse disability).
Unit of Measure: Score
Measured: From preoperative baseline assessment up to 12 months post-surgery
Change from baseline in Neck Dissection Impairment Index (NDII) score
Subjective shoulder-related quality of life will be assessed using the NDII questionnaire (0-50 scale, higher scores indicate greater impairment).
Unit of Measure: Score
Measured: From preoperative baseline assessment up to 12 months post-surgery
Change from baseline in shoulder abduction active range of motion (degrees
Shoulder abduction active range of motion will be measured using goniometry. A clinically significant decline is defined as a ≥23° decrease compared to preoperative baseline.
Unit of Measure: Degrees
Measured: From preoperative baseline assessment up to 12 months post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2025
- Study start25 Jan 2021
- Primary completion12 Aug 2026 (estimated)
- Study completion12 Aug 2026 (estimated)
Why it stopped: Dr Tam have collected the first 20 patients for interim analysis per the protocol, and are trying to get these data to perform interim analyses on these data to best understand how to move forwards.
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.
- More trials run by Henry Ford Health SystemThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 74 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Henry Ford Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Samantha Tam, Henry Ford Health System
- Investigators
- Samantha Tam, MD, Principal investigator, Henry Ford Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07268092
- Sponsor's protocol ID
- HFHS-1901
- Status last verified
- Sep 2025
- First submitted
- 9 Jul 2025
- Last updated
- 5 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Porcine Extracellular Matrix Nerve Wrap on Spinal Accessory Nerve in Patients Undergoing Neck Dissection for Head and Neck Cancer
- ClinicalTrials.gov ID
- NCT07268092
- Acronym / sponsor ID
- HFHS-1901
- Keywords
- Spinal Accessory Nerve Injury, Shoulder Dysfunction, Head and Neck Cancer, Nerve Compression Syndromes, Postoperative Complications
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Dr Tam have collected the first 20 patients for interim analysis per the protocol, and are trying to get these data to perform interim analyses on these data to best understand how to move forwards.
- Enrolment
- 74 participants (estimated)
- Lead sponsor
- Henry Ford Health SystemUniversity, hospital or other
- Study start
- 25 Jan 2021 (actual)
- Primary completion
- 12 Aug 2026 (estimated)
- Study completion
- 12 Aug 2026 (estimated)
- First posted
- 5 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.
Perform a preliminary efficacy study using the porcine extracellular matrix nerve wrap (AxoGuard Nerve Protector™, AxoGen Inc., Alachua, FL) to wrap the spinal accessory nerve (SAN) during neck dissections for head and neck cancer as it relates to postoperative shoulder function, both subjectively and objectively.
Detailed description
Many patients who have surgery for head and neck cancer also need a procedure called a neck dissection, where lymph nodes and tissue are removed from the neck. During this surgery, even when a nerve called the spinal accessory nerve (SAN) is carefully preserved, patients often have shoulder problems afterward. These problems can include pain, weakness, and difficulty lifting the arm, which can affect daily activities and quality of life.
This study is testing whether using a special nerve wrap made from pig tissue (called AxoGuard® Nerve Protector) can help protect the spinal accessory nerve during surgery and improve shoulder movement and strength after surgery. This nerve wrap is already used in other types of nerve surgeries and may help the nerve heal better by reducing scar tissue and irritation.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm - Neck dissection with AxoGuard Nerve Protector™ | Experimental | Device: Porcine Extracellular Matrix Nerve Wrap (AxoGuard Nerve Protector™)Participants undergo neck dissection surgery for head and neck cancer, during which the spinal accessory nerve (SAN) is wrapped with the AxoGuard Nerve Protector™ (porcine extracellular matrix nerve wrap). This intervention aims to improve postoperative shoulder function by protecting and supporting the nerve during healing. Postoperative physical therapy evaluations will be conducted at baseline, immediate post-op, 1, 6, and 12 months. |
| Control Arm - Neck dissection without AxoGuard Nerve Protector™. | No intervention | –Participants undergo standard neck dissection surgery for head and neck cancer without the application of the AxoGuard Nerve Protector™. Postoperative physical therapy evaluations will be conducted at baseline, immediate post-op, 1, 6, and 12 months to assess shoulder function. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients at least 18 years old
- Patients with no previous treatment of head and neck cancer
- Patients with no prior neck surgeries
- Patients undergoing level IIA and IIB neck diss
Key exclusion criteria (9 listed)
- Patients with previously treated head and neck cancers
- Patients undergoing level V neck dissection
- Patients undergoing bilateral neck dissection
- Patients with previous neck surgery unrelated to head and neck cancer
- Patients allergic to porcine products or with religious/cultural restrictions on porcine products
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 |
|---|---|---|
| Porcine Extracellular Matrix Nerve Wrap (AxoGuard Nerve Protector™)The intervention involves the application of the AxoGuard Nerve Protector™, a nerve wrap derived from porcine extracellular matrix (ECM), to the spinal accessory nerve (SAN) during neck dissection surgery in head and neck cancer patients. The device is designed to protect and support the nerve by preserving the extracellular matrix and creating a favorable environment for nerve healing. This helps prevent inflammation and fibrosis around the nerve, potentially improving postoperative shoulder function. The nerve wrap is applied intraoperatively after dissection but before surgical closure. The study compares this intervention to standard neck dissection without nerve wrapping. | Device | Treatment Arm - Neck dissection with AxoGuard Nerve Protector™ |
Primary outcome
Change from baseline in shoulder flexion active range of motion (degrees)
Time frame: From preoperative baseline assessment up to 12 months post-surgery
Shoulder flexion active range of motion will be measured using goniometry. A clinically significant decline is defined as a ≥12° decrease compared to preoperative baseline. Unit of Measure: Degrees
Change from baseline in Quick Disabilities of the Arm, Shoulder, and Hand (QuickDASH) score
Time frame: From preoperative baseline assessment up to 12 months post-surgery
Subjective upper extremity function will be assessed using the QuickDASH questionnaire (0-100 scale, higher scores indicate worse disability). Unit of Measure: Score
Change from baseline in Neck Dissection Impairment Index (NDII) score
Time frame: From preoperative baseline assessment up to 12 months post-surgery
Subjective shoulder-related quality of life will be assessed using the NDII questionnaire (0-50 scale, higher scores indicate greater impairment). Unit of Measure: Score
Change from baseline in shoulder abduction active range of motion (degrees
Time frame: From preoperative baseline assessment up to 12 months post-surgery
Shoulder abduction active range of motion will be measured using goniometry. A clinically significant decline is defined as a ≥23° decrease compared to preoperative baseline. Unit of Measure: Degrees
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2025.
- Individual participant dataSharing planned: No
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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.
Samantha Tam, MD principal investigator
Henry Ford Health System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Porcine Extracellular Matrix Nerve Wrap (AxoGuard Nerve Protector™) in people with Head and Neck Cancer and Neck Dissection, run by Henry Ford Health System 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 9 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: paused, as of the sponsor's last update on 5 Dec 2025. 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?
Results are not available in the source record.
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?
Change from baseline in shoulder flexion active range of motion (degrees) (time frame: From preoperative baseline assessment up to 12 months post-surgery). The study lists 4 primary outcomes in all. 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 5 Dec 2025.