Ignite Creation Date:
2025-12-24 @ 3:53 PM
Ignite Modification Date:
2026-01-06 @ 4:31 AM
Study NCT ID:
NCT07268092
Status:
SUSPENDED
Last Update Posted:
2025-12-05
First Post:
2025-07-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Porcine Extracellular Matrix Nerve Wrap in Neck Dissection for Head and Neck Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D061227', 'term': 'Accessory Nerve Injuries'}, {'id': 'D009408', 'term': 'Nerve Compression Syndromes'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D020436', 'term': 'Accessory Nerve Diseases'}, {'id': 'D003389', 'term': 'Cranial Nerve Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D020209', 'term': 'Cranial Nerve Injuries'}, {'id': 'D006259', 'term': 'Craniocerebral Trauma'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 74}}, 'statusModule': {'whyStopped': '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.', 'overallStatus': 'SUSPENDED', 'startDateStruct': {'date': '2021-01-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2026-08-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-03', 'studyFirstSubmitDate': '2025-07-09', 'studyFirstSubmitQcDate': '2025-12-03', 'lastUpdatePostDateStruct': {'date': '2025-12-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-08-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline in shoulder flexion active range of motion (degrees)', 'timeFrame': 'From preoperative baseline assessment up to 12 months post-surgery', 'description': '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.\n\nUnit of Measure: Degrees'}, {'measure': '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', 'description': 'Subjective upper extremity function will be assessed using the QuickDASH questionnaire (0-100 scale, higher scores indicate worse disability).\n\nUnit of Measure: Score'}, {'measure': 'Change from baseline in Neck Dissection Impairment Index (NDII) score', 'timeFrame': 'From preoperative baseline assessment up to 12 months post-surgery', 'description': 'Subjective shoulder-related quality of life will be assessed using the NDII questionnaire (0-50 scale, higher scores indicate greater impairment).\n\nUnit of Measure: Score'}, {'measure': 'Change from baseline in shoulder abduction active range of motion (degrees', 'timeFrame': 'From preoperative baseline assessment up to 12 months post-surgery', 'description': '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.\n\nUnit of Measure: Degrees'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Spinal Accessory Nerve Injury', 'Shoulder Dysfunction', 'Head and Neck Cancer', 'Nerve Compression Syndromes', 'Postoperative Complications'], 'conditions': ['Head and Neck Cancer', 'Neck Dissection', 'Postoperative Complications']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nThis 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients at least 18 years old\n* Patients with no previous treatment of head and neck cancer\n* Patients with no prior neck surgeries\n* Patients undergoing level IIA and IIB neck diss\n\nExclusion Criteria:\n\n* Patients with previously treated head and neck cancers\n* Patients undergoing level V neck dissection\n* Patients undergoing bilateral neck dissection\n* Patients with previous neck surgery unrelated to head and neck cancer\n* Patients allergic to porcine products or with religious/cultural restrictions on porcine products\n* Patients unable to consent\n* Individuals who are not adults (infants, children, teenagers)\n* Pregnant women\n* Prisoners'}, 'identificationModule': {'nctId': 'NCT07268092', 'briefTitle': 'Porcine Extracellular Matrix Nerve Wrap in Neck Dissection for Head and Neck Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Henry Ford Health System'}, 'officialTitle': 'Impact of Porcine Extracellular Matrix Nerve Wrap on Spinal Accessory Nerve in Patients Undergoing Neck Dissection for Head and Neck Cancer', 'orgStudyIdInfo': {'id': 'HFHS-1901'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment Arm - Neck dissection with AxoGuard Nerve Protector™', 'description': '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.', 'interventionNames': ['Device: Porcine Extracellular Matrix Nerve Wrap (AxoGuard Nerve Protector™)']}, {'type': 'NO_INTERVENTION', 'label': 'Control Arm - Neck dissection without AxoGuard Nerve Protector™.', 'description': '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.'}], 'interventions': [{'name': 'Porcine Extracellular Matrix Nerve Wrap (AxoGuard Nerve Protector™)', 'type': 'DEVICE', 'description': '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.', 'armGroupLabels': ['Treatment Arm - Neck dissection with AxoGuard Nerve Protector™']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48202', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Henry Ford Health System', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}], 'overallOfficials': [{'name': 'Samantha Tam, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Henry Ford Health System'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Henry Ford Health System', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Vice Chair-Otolaryngology • Otolaryngology', 'investigatorFullName': 'Samantha Tam', 'investigatorAffiliation': 'Henry Ford Health System'}}}}