Ignite Creation Date:
2025-12-24 @ 12:09 PM
Ignite Modification Date:
2025-12-27 @ 9:36 PM
Study NCT ID:
NCT07283861
Status:
RECRUITING
Last Update Posted:
2025-12-23
First Post:
2025-12-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Axoguard HA Plus Nerve Protector to Reduce Post-operative Neck and Shoulder Dysfunction in Patients Undergoing Neck Dissection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006258', 'term': 'Head and Neck Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-12-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2028-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-20', 'studyFirstSubmitDate': '2025-12-06', 'studyFirstSubmitQcDate': '2025-12-06', 'lastUpdatePostDateStruct': {'date': '2025-12-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2027-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'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.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['shoulder function', 'neck dissection', 'head and neck cancer'], 'conditions': ['Head and Neck Cancer', 'Neck Dissection']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Previously untreated malignancy of the head and neck including primary mucosal, cutaneous, salivary gland, and thyroid cancers\n* Undergoing accessory-nerve sparing elective or therapeutic SND or MRND (involving level II and/or level V dissection)\n* 18 years or older\n* Patients must give documented informed consent to participate in this study\n\nExclusion Criteria:\n\n* Previous history of neck or shoulder surgery or radiation\n* Inadvertent injury to or intentional sacrifice of the accessory nerve at time of neck dissection\n* Medical contraindication to surgery under general anesthesia\n* Known sensitivity to porcine materials\n* Pregnant or lactating patients\n* Incarcerated patients'}, 'identificationModule': {'nctId': 'NCT07283861', 'briefTitle': 'Axoguard HA Plus Nerve Protector to Reduce Post-operative Neck and Shoulder Dysfunction in Patients Undergoing Neck Dissection', 'organization': {'class': 'OTHER', 'fullName': 'University of Pittsburgh'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'STUDY25060040'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Axoguard HA+ Arm', 'interventionNames': ['Device: Spinal Accessory Nerve Protection utilizing Axoguard HA+']}], 'interventions': [{'name': 'Spinal Accessory Nerve Protection utilizing Axoguard HA+', 'type': 'DEVICE', 'description': 'Nerve protection utilizing a nerve wrap.', 'armGroupLabels': ['Axoguard HA+ Arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '15213', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Matthew E Spector, MD', 'role': 'CONTACT', 'email': 'spectorme@upmc.edu', 'phone': '412-647-2100'}], 'facility': 'UPMC Presbyterian Shadyside', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}], 'centralContacts': [{'name': 'Matthew E Spector, MD', 'role': 'CONTACT', 'email': 'spectorme@upmc.edu', 'phone': '412-647-2100'}], 'overallOfficials': [{'name': 'Daniel Zandberg', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Pittsburgh'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR'], 'timeFrame': '12-1-25 to completion of study', 'ipdSharing': 'YES', 'description': 'Available upon request', 'accessCriteria': 'Available upon request'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Matthew Spector', 'class': 'OTHER'}, 'collaborators': [{'name': 'Axogen Corporation', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Matthew Spector', 'investigatorAffiliation': 'University of Pittsburgh'}}}}