NCT07283861Active, not recruiting
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
Source: ClinicalTrials.gov · Last updated 12 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 90 (estimated)
- First submitted
- 6 Dec 2025
- Start date
- 9 Dec 2025
- Primary completion date
- Jan 2027
- Lead sponsor
- Matthew Spector
- Diseases
- Head and neck cancer
- NCT number
- NCT07283861
What you commit to
- Study type: Interventional
- Planned participants: 90
- From 9 Dec 2025 to the primary completion date, Jan 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous history of neck or shoulder surgery or radiation
- Medical contraindication to surgery under general anesthesia
Other
- Inadvertent injury to or intentional sacrifice of the accessory nerve at time of neck dissection
- Known sensitivity to porcine materials
- Pregnant or lactating patients
- Incarcerated patients
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| UPMC Presbyterian Shadyside Coordinator of this site? Confirm its status | Pittsburgh | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.