Ignite Creation Date:
2025-12-24 @ 10:29 PM
Ignite Modification Date:
2025-12-25 @ 8:02 PM
Study NCT ID:
NCT06806735
Status:
RECRUITING
Last Update Posted:
2025-02-07
First Post:
2025-01-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Measuring the Volumes of Hypertrophic Scars and Keloids, Two Specific Kind of Scars, Over Different Points in Time in Patients Who Have Undergone Surgery and Evaluate 3D-cameras As a Possible Measuring and Documenting Tool Including Volumetry
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017439', 'term': 'Cicatrix, Hypertrophic'}, {'id': 'D007627', 'term': 'Keloid'}], 'ancestors': [{'id': 'D002921', 'term': 'Cicatrix'}, {'id': 'D005355', 'term': 'Fibrosis'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D003095', 'term': 'Collagen Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}, 'targetDuration': '1 Year', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-01-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2025-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-04', 'studyFirstSubmitDate': '2025-01-21', 'studyFirstSubmitQcDate': '2025-02-03', 'lastUpdatePostDateStruct': {'date': '2025-02-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Measurability', 'timeFrame': 'Day 0, Month 3, 6 and 12', 'description': 'The objective of this study is to determine the feasibility of utilizing 3D cameras to accurately measure hypertrophic scars and keloids. The primary outcome of this study is the measurement of the volumes of hypertrophic scars in cubic millimeters (equivalent to milliliters) over a period of one year. This will allow for an evaluation of the accuracy of 3D photography and for the observation of any potential changes.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Keloid Scar Following Surgery', 'Scars, Hypertrophic', 'Scar Keloid']}, 'descriptionModule': {'briefSummary': 'Measuring the volumes of hypertrophic scars and keloids, two specific kind of scars, over different points in time in patients who have undergone surgery and evaluate 3D-cameras as a possible measuring and documenting tool including volumetry.', 'detailedDescription': 'The objective of this study is to utilize a 3D camera to measure the volumes of hypertrophic scars and keloids in patients at specified time points. The time points for measurement include day 0, as well as 3, 6, and 12 months. The 3D camera will be evaluated for their efficacy in measuring and documenting the volumes of the scars. This evaluation will include volumetry, which is the measurement of the three-dimensional space occupied by an object.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with hypertrophic scars or keloids of the University Hospital Zurich', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients with hypertrophic scars or keloids, written consent to participate in the study, minimum age of 18 years.\n\nExclusion Criteria:\n\n* Absence of written consent, unwillingness to contribute data, inability to understand the study protocol.\n* lack of hypertrophic scars or keloid'}, 'identificationModule': {'nctId': 'NCT06806735', 'briefTitle': 'Measuring the Volumes of Hypertrophic Scars and Keloids, Two Specific Kind of Scars, Over Different Points in Time in Patients Who Have Undergone Surgery and Evaluate 3D-cameras As a Possible Measuring and Documenting Tool Including Volumetry', 'organization': {'class': 'OTHER', 'fullName': 'University of Zurich'}, 'officialTitle': 'Quantification of Hypertrophic Scar Tissue or Keloid Using a 3D-Camera', 'orgStudyIdInfo': {'id': '2024-01147'}}, 'armsInterventionsModule': {'interventions': [{'name': '3D-Pictures', 'type': 'OTHER', 'description': '3D-Pictures will be taken of hypertrophic scars and keloids to document them.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '8091', 'city': 'Zurich', 'state': 'Canton of Zurich', 'status': 'RECRUITING', 'country': 'Switzerland', 'contacts': [{'name': 'Michael Prof. Dr. med. Soyka', 'role': 'CONTACT', 'email': 'rhinologie@usz.ch', 'phone': '+41 44 255 58 33'}], 'facility': 'Universitätsspital Zürich', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}], 'centralContacts': [{'name': 'Prof. Dr. med. Soyka', 'role': 'CONTACT', 'email': 'rhinologie@usz.ch', 'phone': '+41 44 255 58 33'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Zurich', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}