Ignite Creation Date:
2025-12-24 @ 7:43 PM
Ignite Modification Date:
2026-03-04 @ 10:24 PM
Study NCT ID:
NCT04191603
Status:
UNKNOWN
Last Update Posted:
2020-06-23
First Post:
2019-12-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
TWO DİFFERENT ELECTROSURGERY DEVICES AS MONOPOLAR HOOC AND PLASMAKINETIC BIPOLAR SPATULA EFFECTIVENESS DURING COLPOTOMY
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007889', 'term': 'Leiomyoma'}, {'id': 'D010048', 'term': 'Ovarian Cysts'}, {'id': 'D004714', 'term': 'Endometrial Hyperplasia'}, {'id': 'D002578', 'term': 'Uterine Cervical Dysplasia'}], 'ancestors': [{'id': 'D009379', 'term': 'Neoplasms, Muscle Tissue'}, {'id': 'D018204', 'term': 'Neoplasms, Connective and Soft Tissue'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D003560', 'term': 'Cysts'}, {'id': 'D010049', 'term': 'Ovarian Diseases'}, {'id': 'D000291', 'term': 'Adnexal Diseases'}, {'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': 'D006058', 'term': 'Gonadal Disorders'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D014591', 'term': 'Uterine Diseases'}, {'id': 'D011230', 'term': 'Precancerous Conditions'}, {'id': 'D002577', 'term': 'Uterine Cervical Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR'], 'maskingDescription': 'MONOPOLAR HOOC VERSUS PLASMAKINETIC BIPOLAR SPATULA USAGE DURING COLPOTOMY'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'MONOPOLAR HOOC VERSUS PLASMAKINETIC BIPOLAR SPATULA USAGE DURING COLPOTOMY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2020-10-30', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-06', 'completionDateStruct': {'date': '2021-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-06-21', 'studyFirstSubmitDate': '2019-12-04', 'studyFirstSubmitQcDate': '2019-12-05', 'lastUpdatePostDateStruct': {'date': '2020-06-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-12-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'VAGINAL DEHISSENS', 'timeFrame': '0 DAY-365 DAYS', 'description': 'AFTER LAPAROSCOPIC HYSTERECTOMY TWO DIFFERENT ELECTROSURGERY DEVICES RESULTS'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Uterine Fibroid', 'Ovary Cyst', 'Endometrial Hyperplasia', 'Cervical Dysplasia']}, 'descriptionModule': {'briefSummary': 'WE DECIDED TO COMPARE TWO DIFFERENT ELECTROSURGERY DEVİCES TO PROVIDE COLPOTOMY. ONE OF THEM İS MONOPOLAR HOOC, THE OTHER DEVİCE İS PLASMAKİNETİC BİPOLAR SPATULA. WE WİLL RANDOMİSE PATİENTS FİRSTLY THEN COMPARE THE RESULTS SUCH, VAGİNAL DEHİSSENS, COLPOTOMY DURATİON, AMOUNT OF MIST DURING COLPOTOMY, AMOUNT OF BLEEDİNG.', 'detailedDescription': 'COLPOTOMY IS A PROCESS DURING TOTAL LAPAROSCOPIC HYSTERECTOMY. WE CAN USE EİTHER ELECTROSURGERY INSTRUMENTS TO PROVIDE COLPOTOMY. IN OUR TRIAL WE WİLL RANDOMİSE PATİENTS FİRSTLY THEN COMPARE THE RESULTS SUCH, VAGİNAL DEHİSSENS, COLPOTOMY DURATİON, AMOUNT OF MIST DURING COLPOTOMY, AMOUNT OF BLEEDİNG.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '30 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* APPROPIATE FOR TOTAL LAPAROSCOPIC HYSTERECTOMY\n\nExclusion Criteria:\n\n* MALIGNANCY'}, 'identificationModule': {'nctId': 'NCT04191603', 'briefTitle': 'TWO DİFFERENT ELECTROSURGERY DEVICES AS MONOPOLAR HOOC AND PLASMAKINETIC BIPOLAR SPATULA EFFECTIVENESS DURING COLPOTOMY', 'organization': {'class': 'OTHER', 'fullName': 'Alkü Alanya Education and Research Hospital'}, 'officialTitle': 'THE EFFECTIVENESS OF MONOPOLAR HOOC VERSUS PLASMAKINETIC BİPOLAR SPATULA USAGE DURING COLPOTOMY PROCESS IN PATIENTS UNDERGOİNG TOTAL LAPAROSCOPIC HYSTERECTOMY', 'orgStudyIdInfo': {'id': 'ALKU ERH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'MONOPOLAR HOOC', 'description': 'COLPOTOMY WITH USAGE MONOPOLAR HOOC', 'interventionNames': ['Device: MONOPOLAR HOOC']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'PLASMAKINETIK BIPOLAR SPATULA', 'description': 'COLPOTOMY WITH USAGE MONOPOLAR HOOC', 'interventionNames': ['Device: PLASMAKINETIC BIPOLAR SPATULA']}], 'interventions': [{'name': 'MONOPOLAR HOOC', 'type': 'DEVICE', 'description': 'COLPOTOMY WITH MONOPOLAR HOOC', 'armGroupLabels': ['MONOPOLAR HOOC']}, {'name': 'PLASMAKINETIC BIPOLAR SPATULA', 'type': 'DEVICE', 'description': 'COLPOTOMY WITH BIPOLAR SPATULA', 'armGroupLabels': ['PLASMAKINETIK BIPOLAR SPATULA']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Antalya', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'MERAL TUĞBA ÇİMŞİR', 'role': 'CONTACT', 'email': 'DR.TUGBAACAR@GMAİL.COM', 'phone': '05064742272'}], 'facility': 'Alku Alanya Education and Research Hospital', 'geoPoint': {'lat': 36.90812, 'lon': 30.69556}}], 'centralContacts': [{'name': 'MERAL TUĞBA ÇİMŞİR', 'role': 'CONTACT', 'email': 'dr.tugbaacar@gmail.com', 'phone': '05064742272'}], 'overallOfficials': [{'name': 'MERAL TUĞBA ÇİMŞİR', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'ALKU EDUCATİON AND RESEARCH HOSPITAL'}]}, 'ipdSharingStatementModule': {'infoTypes': ['CSR'], 'timeFrame': '5 YEARS', 'ipdSharing': 'YES', 'description': '5 YEARS'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alkü Alanya Education and Research Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'ASSOCIATE PROFESSOR', 'investigatorFullName': 'MERAL TUĞBA ÇİMŞİR', 'investigatorAffiliation': 'Alkü Alanya Education and Research Hospital'}}}}