Clinical trial · Interventional
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
| Neck Dissection | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Spinal Accessory Nerve Protection utilizing Axoguard HA+ | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Axoguard HA+ Arm
- interventionNames
- Device: Spinal Accessory Nerve Protection utilizing Axoguard HA+
Primary outcomes (1)
- measure
- One year neck and shoulder dysfunction as assessed by the neck dissection impairment index
- timeFrame
- one year
- description
- The neck dissection impairment index is a score from 1-100 with 100 being a perfect score.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available