Ignite Creation Date:
2025-12-26 @ 4:03 PM
Ignite Modification Date:
2026-01-27 @ 5:02 AM
Study NCT ID:
NCT05668806
Status:
COMPLETED
Last Update Posted:
2022-12-30
First Post:
2022-11-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
RWE Study in the Treatment of Cervical Lesions of Various Etiology
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014592', 'term': 'Uterine Hemorrhage'}, {'id': 'D019522', 'term': 'Vaginal Discharge'}], 'ancestors': [{'id': 'D014591', 'term': 'Uterine 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': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D014623', 'term': 'Vaginal Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 345}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-05-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-12', 'completionDateStruct': {'date': '2021-07-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-12-24', 'studyFirstSubmitDate': '2022-11-18', 'studyFirstSubmitQcDate': '2022-12-24', 'lastUpdatePostDateStruct': {'date': '2022-12-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-12-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-07-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of treatment-related adverse events in subjects participating in the clinical investigation', 'timeFrame': '3 months', 'description': 'Number of participants with treatment-related adverse events as assessed by CTCAE v5.0'}], 'secondaryOutcomes': [{'measure': 'Clinical Performance assessed by the investigator', 'timeFrame': '3 months', 'description': 'An assessment of the cervical lesions by gynecological examination (visual evaluation)'}, {'measure': 'Patient Satisfaction', 'timeFrame': '3 months', 'description': 'An assessment on a 5-point Likert scale to evaluate the degree of satisfaction after the treatment. The scale rates satisfaction from Very satisfied (maximum) to Very unsatisfied (minimum).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['cervical ectropion', 'vaginal discharge', 'cervix lesion'], 'conditions': ['Cervical Lesion', 'Vaginal Bleeding']}, 'referencesModule': {'references': [{'pmid': '37546352', 'type': 'DERIVED', 'citation': 'Petre I, Sirbu DT, Petrita R, Toma AD, Peta E, Dimcevici-Poesina F. Real-world study of Cerviron(R) vaginal ovules in the treatment of cervical lesions of various etiologies. Biomed Rep. 2023 Jul 7;19(2):54. doi: 10.3892/br.2023.1618. eCollection 2023 Aug.'}]}, 'descriptionModule': {'briefSummary': 'The aim of the study was to assess the post-market performance and tolerability of Cerviron® ovules in the treatment and management of cervical lesions of different etiologies. The study included clinical data related to aspect of lesions performed during routine colposcopy exams, the degree of re-epithelialization of the cervical mucosa, vaginal pH, pain level, and vaginal bleeding level.', 'detailedDescription': "This study is an observational, post-marketing study conducted between May-July 2021.\n\nThe aim of the study was to assess the post-market performance and tolerability of Cerviron® ovules in the treatment and management of cervical lesions of different etiologies.\n\nThe secondary objective of this clinical investigation is the assessment of performance of the medical device by clinical exam and patients' degree of satisfaction related to the use of the medical device.\n\nThe study population included 345 participants aged 20-70 years with either a cervical lesion under treatment or with recent surgical removal of a cervical lesion."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Women aged above 18 years with a clearly diagnosed non-infectious gynecological disease and patients with traumatic or surgical lesions.', 'genderDescription': 'Women who are taking oral contraceptives often have cervical ectopy (cervical erosions).', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with a clearly diagnosed non-infectious gynecological disease and patients with traumatic or surgical lesions.\n* Patients with either of the following medical history: trauma of the cervix, pain, bleeding after sexual intercourse, postpartum injuries or postoperative cervical lesions.\n\nExclusion Criteria:\n\n* Patients with cervical cancer.\n* Patients with vulvar cancer'}, 'identificationModule': {'nctId': 'NCT05668806', 'briefTitle': 'RWE Study in the Treatment of Cervical Lesions of Various Etiology', 'organization': {'class': 'INDUSTRY', 'fullName': 'Perfect Care Distribution'}, 'officialTitle': 'Study of Real-world Evidence in Patients Treated With Cerviron Vaginal Ovules in the Treatment of Cervical Lesions of Various Etiology', 'orgStudyIdInfo': {'id': 'CYRONRW/02/2022'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Cerviron', 'type': 'DEVICE', 'description': 'Cerviron® is an invasive medical device of short-term use classified under annex VIII of the European Regulation 2017/745 as class IIb according to Rule 21 (devices composed of substances or of combinations of substances to be introduced into the human body via a body orifice or applied to the skin and absorbed by or locally dispersed in the human body). Cerviron® has a complex composition consisting of three topical pharmaceutical products - hexylresorcinol, collagen and bismuth subgallate - and four phytotherapeutic extracts - Calendula officinalis, Hydrastis canadensis, Thymus vulgaris extract and Curcuma longa. The Instructions for use specify its field of use as adjuvant in the treatment of acute and chronic vulvovaginitis of mechanical etiology, caused by changes of vaginal pH and changes of the vaginal flora and of cervical lesions of mechanical origin.'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bucharest', 'country': 'Romania', 'facility': 'Spitalul Clinic Dr. Ion Cantacuzino Bucharest', 'geoPoint': {'lat': 44.43225, 'lon': 26.10626}}, {'city': 'Cluj-Napoca', 'country': 'Romania', 'facility': 'Med Life Humanitas Cluj-Napoca', 'geoPoint': {'lat': 46.76667, 'lon': 23.6}}, {'city': 'Craiova', 'country': 'Romania', 'facility': 'Cabinet Medical - Dr. Saleh K. Majed', 'geoPoint': {'lat': 44.31667, 'lon': 23.8}}, {'city': 'Iași', 'country': 'Romania', 'facility': 'Cabinet Medical - Dr. Surpanelu Oana', 'geoPoint': {'lat': 47.16667, 'lon': 27.6}}, {'city': 'Iași', 'country': 'Romania', 'facility': 'MediBlue', 'geoPoint': {'lat': 47.16667, 'lon': 27.6}}, {'city': 'Piteşti', 'country': 'Romania', 'facility': 'Clinica Natisan Pitesti', 'geoPoint': {'lat': 44.85, 'lon': 24.86667}}, {'city': 'Râmnicu Vâlcea', 'country': 'Romania', 'facility': 'Cabinet Dr. Rădulescu G. Mihaela Elena', 'geoPoint': {'lat': 45.1, 'lon': 24.36667}}, {'city': 'Râmnicu Vâlcea', 'country': 'Romania', 'facility': 'Ramnicu Valcea', 'geoPoint': {'lat': 45.1, 'lon': 24.36667}}, {'city': 'Sibiu', 'country': 'Romania', 'facility': 'Cabinet Ginecologic Dr. Popescu Sibiu', 'geoPoint': {'lat': 45.8, 'lon': 24.15}}, {'city': 'Sibiu', 'country': 'Romania', 'facility': 'Clinica iMED', 'geoPoint': {'lat': 45.8, 'lon': 24.15}}, {'city': 'Sibiu', 'country': 'Romania', 'facility': 'Pan Medical Sibiu', 'geoPoint': {'lat': 45.8, 'lon': 24.15}}, {'city': 'Târgu Jiu', 'country': 'Romania', 'facility': 'Bradmed SRL', 'geoPoint': {'lat': 45.05, 'lon': 23.28333}}, {'city': 'Târgu Jiu', 'country': 'Romania', 'facility': 'Cabinet Dr. Ioana Trotea Targu Jiu', 'geoPoint': {'lat': 45.05, 'lon': 23.28333}}, {'city': 'Timișoara', 'country': 'Romania', 'facility': 'Clinica Medicala Dr. Cioata Ionel Trifon', 'geoPoint': {'lat': 45.75372, 'lon': 21.22571}}, {'city': 'Tulcea', 'country': 'Romania', 'facility': 'Spitalul Judetean de Urgenta Tulcea', 'geoPoint': {'lat': 45.1787, 'lon': 28.80501}}], 'overallOfficials': [{'name': 'Ema Peta', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Perfect Care Distribution'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Perfect Care Distribution', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'MDX Research', 'class': 'NETWORK'}], 'responsibleParty': {'type': 'SPONSOR'}}}}