Ignite Creation Date:
2025-12-25 @ 1:19 AM
Ignite Modification Date:
2025-12-25 @ 11:27 PM
Study NCT ID:
NCT05712993
Status:
COMPLETED
Last Update Posted:
2023-02-06
First Post:
2023-01-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparative Study Between Transcoronoid and Infrazygomatic Anterior Maneuvers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014277', 'term': 'Trigeminal Neuralgia'}], 'ancestors': [{'id': 'D020433', 'term': 'Trigeminal Nerve Diseases'}, {'id': 'D005156', 'term': 'Facial Neuralgia'}, {'id': 'D005155', 'term': 'Facial Nerve Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D003389', 'term': 'Cranial Nerve Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2022-08-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-01-26', 'studyFirstSubmitDate': '2023-01-16', 'studyFirstSubmitQcDate': '2023-01-26', 'lastUpdatePostDateStruct': {'date': '2023-02-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-02-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-08-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '1-efficacy and safety of infrazygomatic anterior out of plane 2- how can infrazygomatic maneuver can help in decrease the chance of targeting V3 in addition V2 during injection', 'timeFrame': '2 years', 'description': 'new method used to target V2 to decrease the chance of failure and to lessen the number of trials required the tools of measurement was the stimulation in volt and number of trial by No.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Trigeminal Neuralgia']}, 'descriptionModule': {'briefSummary': 'new technique in targeting V2 under ultrasound guidance', 'detailedDescription': 'the classical approach of V2 transcoronoin for practitioner is considered as difficult with significant failure rate with sustained V3 motor stimulation our approach infrazygomatic anterior out of plane is considered much easier in achieving pure V2 stimulation without V3 which make the thermal radio frequency 80 Celsius can be performed safely'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:above 40 severe pain normal neurological examination -\n\nExclusion Criteria:metastasis allergy to medication used radio frequency precautions previous failed radio frequency or microvascular decompression gamma knife coagulpathy sepsis or active infection at site of needle entry\n\n\\-'}, 'identificationModule': {'nctId': 'NCT05712993', 'briefTitle': 'Comparative Study Between Transcoronoid and Infrazygomatic Anterior Maneuvers', 'organization': {'class': 'OTHER', 'fullName': 'Iraqi Board of medical specialties'}, 'officialTitle': 'Comparative Study Between Transcoronoid and Infrazygomatic Anterior Maneuvers to Localize the Maxillary Nerve Under Ultrasound Guidance', 'orgStudyIdInfo': {'id': 'IraqBoard'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'transcoronoid', 'description': 'participants are TN patients complain TN without secondary causes of trigeminal neuralgia underwent V2 targeting through coronoid notch', 'interventionNames': ['Procedure: V2 thermal radio frequency']}, {'type': 'EXPERIMENTAL', 'label': 'infrazygomatic anterior out of plane', 'description': 'participants are TN patients complain TN without secondary causes of trigeminal neuralgia underwent V2 targeting through infrazygomatic anterior out of plane', 'interventionNames': ['Procedure: V2 thermal radio frequency']}], 'interventions': [{'name': 'V2 thermal radio frequency', 'type': 'PROCEDURE', 'description': 'V2 targeted thermal radio frequency safely without sustained V3 stimulation', 'armGroupLabels': ['infrazygomatic anterior out of plane', 'transcoronoid']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10001', 'city': 'Baghdad', 'country': 'Iraq', 'facility': 'Mohammed Mahdi', 'geoPoint': {'lat': 33.34058, 'lon': 44.40088}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': '40 participants enrolled in the study complaining of sever TN with normal neurological examination'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Iraqi Board of medical specialties', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}