Ignite Creation Date:
2025-12-25 @ 2:11 AM
Ignite Modification Date:
2025-12-27 @ 5:15 AM
Study NCT ID:
NCT05273060
Status:
COMPLETED
Last Update Posted:
2025-07-02
First Post:
2022-01-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Regenerative Medicine Approach to Nasal Reconstruction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 7}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-05-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2024-12-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-28', 'studyFirstSubmitDate': '2022-01-09', 'studyFirstSubmitQcDate': '2022-03-04', 'lastUpdatePostDateStruct': {'date': '2025-07-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-03-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Viable nasal reconstruction', 'timeFrame': '6 months', 'description': 'Total number of subjects to have successful nasal reconstruction with transfer of viable tissue to reconstruct nasal defect'}], 'secondaryOutcomes': [{'measure': 'Nasal breathing', 'timeFrame': '6 months', 'description': 'Total number of subjects to have ability to move air through the nose for purposes of breathing'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Nasal Surgical Procedures', 'Regenerative Medicine']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to gather information on the safety and effectiveness and compare nasal reconstruction standard planning versus 3D preoperative scanning/printing/planning.', 'detailedDescription': "Patients with nasal defects from cancer, trauma, prior surgery, or birth often require complex reconstruction. Current techniques involve hand sketched skin templates and/or hand carved cartilage grafts that are formed intraoperatively for nasal reconstruction. This process is time consuming, heavily depends on the surgeon's skill, cannot be standardized, and is difficult to visualize with patients preoperatively. To overcome these barriers and shift surgical paradigms, we will use a regenerative medicine approach to nasal reconstruction to create patient specific and individualized results. We will leverage regenerative medicine techniques of 3D surface mapping, 3D printing and modeling, and new tissue preparation techniques for skin template creation and sculpting of cartilage grafting. Clinically this will improve patient specific outcomes, increase reproducibility, reduce operative times, and allow for an individualized approach to nasal reconstruction. This will be achieved by (1) establishing ideal diced cartilage graft parameters in the laboratory setting for moldable cartilage graft formation. This knowledge will be applied to (2) create diced cartilage grafts for nasal dorsum and tip reconstruction from 3D printed nasal molds. For nasal skin reconstruction, (3) 3D facial scans of patients' preoperatively will be used to generate patient specific templates for skin reconstruction. Ultimately, (4) these regenerative medicine techniques of cartilage and skin reconstruction performed with 3D planning can be shared in an interactive format with patients preoperatively. This will allow patients to be involved in the surgical planning of their nasal reconstruction to increase their autonomy and the individualization of their surgery."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Males or female, age range is ≥ 18 to ≤ 100, based on historical surgical experience.\n* Patients undergoing nasal reconstruction.\n* Patients will be identified from the Facial Plastic Surgery clinic of the PI.\n\nExclusion Criteria:\n\n\\- Patients \\< 18 are excluded because these cases are in combination with providers from PCH and patients have shared/limited postoperative follow up as a result.'}, 'identificationModule': {'nctId': 'NCT05273060', 'briefTitle': 'Regenerative Medicine Approach to Nasal Reconstruction', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'Regenerative Medicine Approach to Nasal Reconstruction', 'orgStudyIdInfo': {'id': '21-004941'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Standard of Care Nasal Reconstruction Planning', 'description': 'Subjects undergoing nasal reconstruction will have standard planning for procedure.'}, {'type': 'EXPERIMENTAL', 'label': '3D Nasal Reconstruction Planning', 'description': 'Subjects undergoing nasal reconstruction will have 3D planning utilized by the surgical team for the procedure.', 'interventionNames': ['Procedure: 3D Nasal Reconstruction Planning']}], 'interventions': [{'name': '3D Nasal Reconstruction Planning', 'type': 'PROCEDURE', 'description': '3D molds or models to use in the reconstruction of nasal cartilage', 'armGroupLabels': ['3D Nasal Reconstruction Planning']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85054', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Mayo Clinic Arizona', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}], 'overallOfficials': [{'name': 'Brittany Howard, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Brittany E. Howard', 'investigatorAffiliation': 'Mayo Clinic'}}}}