Ignite Creation Date:
2025-12-24 @ 4:43 PM
Ignite Modification Date:
2026-01-01 @ 9:42 PM
Study NCT ID:
NCT03877666
Status:
RECRUITING
Last Update Posted:
2025-07-09
First Post:
2019-03-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessment of the Influence of Cleft Repair on Microcirculation of the Palate
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002972', 'term': 'Cleft Palate'}, {'id': 'D002971', 'term': 'Cleft Lip'}], 'ancestors': [{'id': 'D007569', 'term': 'Jaw Abnormalities'}, {'id': 'D007571', 'term': 'Jaw Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D019767', 'term': 'Maxillofacial Abnormalities'}, {'id': 'D019465', 'term': 'Craniofacial Abnormalities'}, {'id': 'D009139', 'term': 'Musculoskeletal Abnormalities'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D009056', 'term': 'Mouth Abnormalities'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D018640', 'term': 'Stomatognathic System Abnormalities'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D008047', 'term': 'Lip Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-08-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-08', 'studyFirstSubmitDate': '2019-03-11', 'studyFirstSubmitQcDate': '2019-03-14', 'lastUpdatePostDateStruct': {'date': '2025-07-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-03-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in tissue perfusion (regional tissue oxygen saturation (StO2%)) before and after surgery non-invasively measured', 'timeFrame': 'One measurement before surgery, one measurement immediately after surgery', 'description': 'The difference and impact of our routine surgical technique on the tissue perfusion of the palate is measured non-invasively with a probe (regional StO2%). Localized measurement of the microvascular hemoglobin oxygen saturation.'}], 'secondaryOutcomes': [{'measure': 'Status of wound healing', 'timeFrame': 'at 3 month and 6 month after surgery', 'description': 'status of wound healing, fistula formation'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cleft Palate', 'Cleft Lip and Palate']}, 'referencesModule': {'references': [{'pmid': '9727428', 'type': 'BACKGROUND', 'citation': 'Huang MH, Lee ST, Rajendran K. Clinical implications of the velopharyngeal blood supply: a fresh cadaveric study. Plast Reconstr Surg. 1998 Sep;102(3):655-67. doi: 10.1097/00006534-199809030-00007.'}, {'pmid': '23096613', 'type': 'BACKGROUND', 'citation': 'Mueller AA, Schumann D, Reddy RR, Schwenzer-Zimmerer K, Mueller-Gerbl M, Zeilhofer HF, Sailer HF, Reddy SG. Intraoperative vascular anatomy, arterial blood flow velocity, and microcirculation in unilateral and bilateral cleft lip repair. Plast Reconstr Surg. 2012 Nov;130(5):1120-1130. doi: 10.1097/PRS.0b013e318267d4fb.'}, {'pmid': '28027255', 'type': 'BACKGROUND', 'citation': 'Woo AS. Evidence-Based Medicine: Cleft Palate. Plast Reconstr Surg. 2017 Jan;139(1):191e-203e. doi: 10.1097/PRS.0000000000002854.'}]}, 'descriptionModule': {'briefSummary': 'Investigators aim to evaluate the influence of cleft surgery on the tissue microcirculation of the palate with a non-invasive measurement.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '13 Months', 'minimumAge': '6 Months', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with orofacial clefts undergoing surgical repair of the deformity.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients with orofacial clefts, who undergo routine cleft repair\n\nExclusion Criteria:\n\n* missing datasets\n* no signed consent for research.'}, 'identificationModule': {'nctId': 'NCT03877666', 'briefTitle': 'Assessment of the Influence of Cleft Repair on Microcirculation of the Palate', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Basel, Switzerland'}, 'officialTitle': 'Intraoperative Assessment of the Influence of Cleft Repair on Microcirculation of the Palate', 'orgStudyIdInfo': {'id': 'Microcirculation Palate'}}, 'contactsLocationsModule': {'locations': [{'zip': '4310', 'city': 'Basel', 'status': 'RECRUITING', 'country': 'Switzerland', 'contacts': [{'name': 'Benito K Benitez, MD, DDS', 'role': 'CONTACT', 'email': 'benito.benitez@usb.ch', 'phone': '615565285', 'phoneExt': '0041'}, {'name': 'Andreas A Mueller, MD, DDS, PhD', 'role': 'CONTACT', 'email': 'andreas.mueller@usb.ch', 'phone': '13286095', 'phoneExt': '0041'}], 'facility': 'Universitätsspital Basel', 'geoPoint': {'lat': 47.55839, 'lon': 7.57327}}], 'centralContacts': [{'name': 'Benito K Benitez, MD DDS MHBA', 'role': 'CONTACT', 'email': 'benito.benitez@usb.ch', 'phone': '615565285', 'phoneExt': '0041'}, {'name': 'Andreas A Mueller, MD DDS PhD', 'role': 'CONTACT', 'email': 'andreas.mueller@usb.ch', 'phone': '613286095', 'phoneExt': '0041'}], 'overallOfficials': [{'name': 'Benito K Benitez, MD DDS MHBA', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Basel and University Hospital Basel'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Basel, Switzerland', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}