Porcine Extracellular Matrix Nerve Wrap in Neck Dissection for Head and Neck Cancer (NCT07268092) | Clinical Trial Compass
SuspendedNot Applicable
Porcine Extracellular Matrix Nerve Wrap in Neck Dissection for Head and Neck Cancer
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.
United States74 participantsStarted 2021-01-25
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
* Individuals who are not adults (infants, children, teenagers)
* Pregnant women
* Prisoners
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change from baseline in shoulder flexion active range of motion (degrees)
Timeframe: From preoperative baseline assessment up to 12 months post-surgery
2
Change from baseline in Quick Disabilities of the Arm, Shoulder, and Hand (QuickDASH) score
Timeframe: From preoperative baseline assessment up to 12 months post-surgery
3
Change from baseline in Neck Dissection Impairment Index (NDII) score
Timeframe: From preoperative baseline assessment up to 12 months post-surgery
4
Change from baseline in shoulder abduction active range of motion (degrees
Timeframe: From preoperative baseline assessment up to 12 months post-surgery