Ignite Creation Date:
2025-12-25 @ 2:49 AM
Ignite Modification Date:
2026-01-01 @ 5:24 AM
Study NCT ID:
NCT05626933
Status:
UNKNOWN
Last Update Posted:
2022-11-25
First Post:
2022-11-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Buccinator Myomucosal Flap With Furlow Palatoplasty and VPI
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014681', 'term': 'Velopharyngeal Insufficiency'}], 'ancestors': [{'id': 'D009056', 'term': 'Mouth Abnormalities'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D010608', 'term': 'Pharyngeal Diseases'}, {'id': 'D018640', 'term': 'Stomatognathic System Abnormalities'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-11-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2023-01-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-11-23', 'studyFirstSubmitDate': '2022-11-15', 'studyFirstSubmitQcDate': '2022-11-23', 'lastUpdatePostDateStruct': {'date': '2022-11-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-11-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'grade of velopharyngeal closure during speech', 'timeFrame': 'immediate postoperative', 'description': 'Nasopharyngoscopic examination of the patients with secondary velopharyngeal insufficiency ( VPI) following two flap palatoplasty cleft palate repairs will be done for assessment of velopharyngeal closure grade during speech after VPI repair by Buccinator myomucosal flap with Furlow palatoplasty'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Velopharyngeal Insufficiency']}, 'referencesModule': {'references': [{'pmid': '38630186', 'type': 'DERIVED', 'citation': 'Aboulhassan MA, Elrouby IM, Refahee SM, Abd-El-Ghafour M. Effectiveness of secondary furlow palatoplasty with buccal myomucosal flap in correction of velopharyngeal insufficiency in patients with cleft palate. Clin Oral Investig. 2024 Apr 17;28(5):257. doi: 10.1007/s00784-024-05607-4.'}]}, 'descriptionModule': {'briefSummary': 'Nasopharyngoscopic examination of the 20 patients with secondary VPI following 2 flap palatoplasty will be done for visualization of the velopharyngeal port, allowing assessment of the pattern and grade of velopharyngeal closure during speech and the presence or absence of a velopharyngeal gap and after VPI repair by Buccinator myomucosal flap with Furlow palatoplasty'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '6 Years', 'minimumAge': '5 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 5-6 years old children with previous treated complete cleft palate with 2 flap palatoplasty technique, nonsyndromic.\n* lip and palate repair performed by one craniofacial surgeon\n\nExclusion Criteria:\n\n* Patients with syndromic cleft lip.\n* Bilateral cleft lip\n* Patient older younger 5 years.\n* Associated Cardiac anomalies.\n* Any systemic condition'}, 'identificationModule': {'nctId': 'NCT05626933', 'briefTitle': 'Buccinator Myomucosal Flap With Furlow Palatoplasty and VPI', 'organization': {'class': 'OTHER', 'fullName': 'Fayoum University'}, 'officialTitle': 'Anatomical Restoration Cleft Palate Technique (ARC) for Secondary Velopharyngeal Incompetence Post Cleft Palate Repair', 'orgStudyIdInfo': {'id': 'EC 2222'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Buccinator myomucosal flap with Furlow palatoplasty', 'interventionNames': ['Procedure: Buccinator myomucosal flap with Furlow palatoplasty']}], 'interventions': [{'name': 'Buccinator myomucosal flap with Furlow palatoplasty', 'type': 'PROCEDURE', 'description': 'Anatomical restoration concept using Buccinator myomucosal flap with Furlow palatoplasty is an effective technique for lengthening the palate and improving speech outcomes', 'armGroupLabels': ['Buccinator myomucosal flap with Furlow palatoplasty']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Al Fayyum', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'shaimaa refahee, phd', 'role': 'CONTACT', 'email': 'smr11@fayoum.edu.eg', 'phone': '01227407987'}], 'facility': 'Fayoum University', 'geoPoint': {'lat': 29.30995, 'lon': 30.8418}}], 'centralContacts': [{'name': 'shaimaa refahee, phd', 'role': 'CONTACT', 'email': 'smr11@fayoum.edu.eg', 'phone': '01227407987'}, {'name': 'mamdouh aboelhassan, phd', 'role': 'CONTACT'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fayoum University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'principal investigator', 'investigatorFullName': 'Shaimaa Mohsen', 'investigatorAffiliation': 'Fayoum University'}}}}