Ignite Creation Date:
2025-12-24 @ 11:08 PM
Ignite Modification Date:
2025-12-25 @ 8:41 PM
Study NCT ID:
NCT01601769
Status:
UNKNOWN
Last Update Posted:
2012-05-18
First Post:
2012-05-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Tissue Sparing Therapy of Female Precancerous Genital Lesions With VITOM
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D003127', 'term': 'Colposcopy'}], 'ancestors': [{'id': 'D003944', 'term': 'Diagnostic Techniques, Obstetrical and Gynecological'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D004724', 'term': 'Endoscopy'}, {'id': 'D003949', 'term': 'Diagnostic Techniques, Surgical'}, {'id': 'D019060', 'term': 'Minimally Invasive Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D013513', 'term': 'Obstetric Surgical Procedures'}, {'id': 'D013509', 'term': 'Gynecologic Surgical Procedures'}, {'id': 'D013519', 'term': 'Urogenital Surgical Procedures'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2011-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-05', 'completionDateStruct': {'date': '2012-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-05-16', 'studyFirstSubmitDate': '2012-05-14', 'studyFirstSubmitQcDate': '2012-05-16', 'lastUpdatePostDateStruct': {'date': '2012-05-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-05-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cervical volume removed', 'timeFrame': 'İmmediately after surgery', 'description': 'Cervical volume removed during the operation is recorded'}, {'measure': 'İntraoperative Complications', 'timeFrame': 'During the intraoperative', 'description': 'Complications encountered during the prodecure'}, {'measure': 'Short term complications', 'timeFrame': 'Within 48 hours after operation', 'description': 'Complications within 48 hours after operation'}, {'measure': 'Late complications', 'timeFrame': 'After 48 hours', 'description': 'Complications occuring after 48 hours'}]}, 'conditionsModule': {'keywords': ['Cervical preinvasive disease', 'Colposcopy', 'Exocolposcopy', 'Leep'], 'conditions': ['Cervical Preinvasive Disease']}, 'descriptionModule': {'briefSummary': 'Object of the study is the evaluation of the use of a rigid laparoscope for the diagnosis and therapy of lesions of the female genital tract as a substitution or a complementary method to colposcopy with the development of new standards for a tissue sparing therapy Use of existing laparoscopic instruments, which allow a better quality level in the diagnosis and therapy than the current routine.\n\nDevelopment of new optics and instruments, which allow a tissue sparing approach Pre and postoperative measurement of the cervical volume, to be sure that the tissue removal is kept to a minimum level Development of qualitaty parameters for the most tissue respecting operations of the uterine cervix Prospective evaluation of the influence of tissue sparing surgery on future pregnancies'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Karnowsky-Index \\> 80,\n* 18-80 years,\n* CIN.\n\nExclusion Criteria:\n\n* Pregnancy,\n* Previous or current cancer,\n* Radio therapy of the pelvis,\n* Serious internistic accompanying diseases,\n* Psychiatric diseases,\n* HIV infection,\n* Drug addiction.'}, 'identificationModule': {'nctId': 'NCT01601769', 'acronym': 'VITOM', 'briefTitle': 'Tissue Sparing Therapy of Female Precancerous Genital Lesions With VITOM', 'organization': {'class': 'OTHER', 'fullName': 'Charite University, Berlin, Germany'}, 'officialTitle': 'Development of a Tissue Sparing Procedure for the Diagnosis and Therapy of Female Precancerous Genital Lesions Combining Endoscopic and Ultrasound Technics.', 'orgStudyIdInfo': {'id': 'ENDOCOLP'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Colposcopy', 'description': 'a Carl Zeiss colposcope with a magnification power from 4x to 20x, with green filter.', 'interventionNames': ['Device: Colposcopy']}, {'type': 'EXPERIMENTAL', 'label': 'Vitom', 'description': 'The VITOM system, consisting of the VITOM scope, xenon light source, HD camera system, AIDA HD documentation system, 1 monitor, and a mechanical support arm (all Karl Storz, Tuttlingen, Germany) is used for video exocolposcopy.', 'interventionNames': ['Device: Vitom']}], 'interventions': [{'name': 'Vitom', 'type': 'DEVICE', 'description': 'Patients treated and diagnosed by vitom', 'armGroupLabels': ['Vitom']}, {'name': 'Colposcopy', 'type': 'DEVICE', 'description': 'a Carl Zeiss colposcope with a magnification power from 4x to 20x, with green filter.\n\nPatients treated by colposcopy', 'armGroupLabels': ['Colposcopy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '12200', 'city': 'Berlin', 'state': 'State of Berlin', 'country': 'Germany', 'facility': 'Charité University Hospital', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}], 'overallOfficials': [{'name': 'Achim Schneider, MD, MPH', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Charité University Hospital, Berlin, Germany'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Charite University, Berlin, Germany', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Giuseppe Vercellino', 'investigatorAffiliation': 'Charite University, Berlin, Germany'}}}}