Ignite Creation Date:
2025-12-25 @ 4:17 AM
Ignite Modification Date:
2025-12-26 @ 3:18 AM
Study NCT ID:
NCT07081620
Status:
RECRUITING
Last Update Posted:
2025-07-23
First Post:
2025-07-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Percutaneous Intercostal Cryoneuromodulation Onset Timing.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005660', 'term': 'Funnel Chest'}], 'ancestors': [{'id': 'D001848', 'term': 'Bone Diseases, Developmental'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D009139', 'term': 'Musculoskeletal Abnormalities'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-06-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2026-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-22', 'studyFirstSubmitDate': '2025-07-07', 'studyFirstSubmitQcDate': '2025-07-22', 'lastUpdatePostDateStruct': {'date': '2025-07-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'thermal sensitivity', 'timeFrame': 'one week (median)', 'description': 'Chest skin thermal sensitivity will be assessed through a "thermofeel" metal instrument set at two different temperatures: 15°C for cold sensation and 40°C for warm sensation. At least 4 different chest zones will be tested to discriminate potential differences. As a validated instument for chest skin thermal assessment does not exist, we will report only qualitative results, as "normal" "impaired" or "absent" sensitivity.'}], 'secondaryOutcomes': [{'measure': 'chest skin sensitivity to touch', 'timeFrame': 'one week (median)', 'description': 'Chest skin mechanical sensitivity will be assessed through both validated von Frey filament testing, and cotton swab for soft touch. At least 4 different chest zones will be tested to discriminate potential differences. We will report qualitative results, as "normal" "impaired" or "absent" sensitivity.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cryoneurolysis', 'Cryoneuromodulation'], 'conditions': ['Cryotherapy Effect', 'Pectus Excavatum']}, 'referencesModule': {'references': [{'pmid': '39510802', 'type': 'BACKGROUND', 'citation': 'Mariconti S, Bronco A, Pellicioli I, Chiudinelli L, Cattaneo M, Cheli M, Bonanomi E. Earlier preoperative percutaneous intercostal cryoanalgesia improves recovery after pectus excavatum surgery. Reg Anesth Pain Med. 2024 Nov 7:rapm-2024-105960. doi: 10.1136/rapm-2024-105960. Online ahead of print.'}]}, 'descriptionModule': {'briefSummary': 'Percutaneous Intercostal Cryoneurolysis is a promising technique that addresses acute postoperative pain after Nuss procedure for pectus excavatum. However its onset timing has not yet been determined. A physical examination would assess the variation of chest skin sensitivity to soft touch, cold (water at 4°C), and heat (water at 40°C) through days following the cryoneurolysis procedure.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '40 Years', 'minimumAge': '12 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Mainly adolescents, mainly males', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who are undergoing preoperative percutaneous intercostal cryoneurolysis for pectus excavatum surgery\n\nExclusion Criteria:\n\n* failure to obtain consent'}, 'identificationModule': {'nctId': 'NCT07081620', 'briefTitle': 'Percutaneous Intercostal Cryoneuromodulation Onset Timing.', 'organization': {'class': 'OTHER', 'fullName': 'Papa Giovanni XXIII Hospital'}, 'officialTitle': 'How Long Does it Take for Percutaneous Intercostal Cryoneuromodulation to Produce Cryoanalgesia? A Prospective Observational Study.', 'orgStudyIdInfo': {'id': 'PICOT1'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Pectus patients', 'description': 'Patients who are eligible for Nuss procedure (for pectus excavatum correction) are undergoing "earlier preoperative percutaneous intercostal cryoneurolysis" in our institution. They are studied through a physical examination also.', 'interventionNames': ['Other: Physical examination of chest skin']}], 'interventions': [{'name': 'Physical examination of chest skin', 'type': 'OTHER', 'description': 'soft touch and thermal (cold and warm) examination', 'armGroupLabels': ['Pectus patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '24100', 'city': 'Bergamo', 'state': 'BG', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Stefano Mariconti', 'role': 'CONTACT'}, {'name': 'Stefano Mariconti, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Papa Giovanni XXIII Hospital', 'geoPoint': {'lat': 45.69601, 'lon': 9.66721}}], 'centralContacts': [{'name': 'Stefano Mariconti, MD', 'role': 'CONTACT', 'email': 'smariconti@asst-pg23.it', 'phone': '00390358347'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Population basic data'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Papa Giovanni XXIII Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Stefano Mariconti', 'investigatorAffiliation': 'Papa Giovanni XXIII Hospital'}}}}