Ignite Creation Date:
2025-12-25 @ 3:54 AM
Ignite Modification Date:
2025-12-26 @ 2:44 AM
Study NCT ID:
NCT04518202
Status:
UNKNOWN
Last Update Posted:
2020-08-19
First Post:
2020-08-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Transdermal Lidocaine for Pain Control During Diagnostic Office Hysteroscopy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007247', 'term': 'Infertility, Female'}], 'ancestors': [{'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D007246', 'term': 'Infertility'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'double blinded randomized controlled trial'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'double blinded randomized controlled trial'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2020-09-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2021-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-08-15', 'studyFirstSubmitDate': '2020-08-15', 'studyFirstSubmitQcDate': '2020-08-15', 'lastUpdatePostDateStruct': {'date': '2020-08-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-08-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-08-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain intensity will be assessed by visual analogue scale', 'timeFrame': '10 minutes', 'description': 'Pain intensity will be assessed by visual analogue scale 30 minutes after the procedure. Visual analogue scale ranging from 0 to 10'}], 'secondaryOutcomes': [{'measure': 'Operative time', 'timeFrame': '15 minutes', 'description': 'From the introduction of hysteroscope into the vagina till compilation of hysteroscopic examination'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Infertility, Female']}, 'descriptionModule': {'briefSummary': 'To compare the effectiveness of Transdermal Lidocaine for Pain Control During Diagnostic Office Hysteroscopy', 'detailedDescription': 'hysteroscopy is commonly used in the diagnosis and treatment of intrauterine lesions such as polyps, fibroids, septa, and adhesions, and in the presence of abnormal bleeding and during the removal of an intrauterine device or foreign body. Cervical ripening is made possible by the use of medication through different routes.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'patients with an indication for office hysteroscopy', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients with an indication for office hysteroscopy\n\nExclusion Criteria:\n\n* patient refuse to participant\n* contraindication for lidocaine patch'}, 'identificationModule': {'nctId': 'NCT04518202', 'briefTitle': 'Transdermal Lidocaine for Pain Control During Diagnostic Office Hysteroscopy', 'organization': {'class': 'OTHER', 'fullName': 'Aswan University Hospital'}, 'officialTitle': 'Transdermal Lidocaine for Pain Control During Diagnostic Office Hysteroscopy: a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'aswu/296/3/19'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'lidocaine patch', 'description': '5% lidocaine patch applied at 6 hours before the scheduled office hysteroscopy.', 'interventionNames': ['Drug: lidocaine patch']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Sham patch', 'description': 'Sham patch applied at 6 hours before the scheduled office hysteroscopy.', 'interventionNames': ['Drug: Sham patch']}], 'interventions': [{'name': 'lidocaine patch', 'type': 'DRUG', 'otherNames': ['Experimental'], 'description': '5% lidocaine patch applied at 6 hours before the scheduled office hysteroscopy.', 'armGroupLabels': ['lidocaine patch']}, {'name': 'Sham patch', 'type': 'DRUG', 'otherNames': ['Placebo Comparator'], 'description': 'Sham patch containing no study medication applied at 6 hours before the scheduled office hysteroscopy.', 'armGroupLabels': ['Sham patch']}]}, 'contactsLocationsModule': {'locations': [{'zip': '81528', 'city': 'Aswān', 'country': 'Egypt', 'facility': 'Aswan University Hospital', 'geoPoint': {'lat': 24.09082, 'lon': 32.89942}}], 'centralContacts': [{'name': 'hany f Sallam, md', 'role': 'CONTACT', 'email': 'hany.farouk@aswu.edu.eg', 'phone': '+20102435461', 'phoneExt': '002'}, {'name': 'nahla w Shady, md', 'role': 'CONTACT', 'email': 'hanygyne@yahoo.com', 'phone': '+201022336052', 'phoneExt': '002'}], 'overallOfficials': [{'name': 'nahla w Shady, md', 'role': 'STUDY_CHAIR', 'affiliation': 'Aswan universirty'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aswan University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'A Professor', 'investigatorFullName': 'hany farouk', 'investigatorAffiliation': 'Aswan University Hospital'}}}}