RWE Study in the Treatment of Cervical Lesions of Various Etiology
NCT ID: NCT05668806
Last Updated: 2022-12-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
345 participants
OBSERVATIONAL
2021-05-20
2021-07-31
Brief Summary
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Detailed Description
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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 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.
The 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.
Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Interventions
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Cerviron
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.
Eligibility Criteria
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Inclusion Criteria
* Patients with either of the following medical history: trauma of the cervix, pain, bleeding after sexual intercourse, postpartum injuries or postoperative cervical lesions.
Exclusion Criteria
* Patients with vulvar cancer
18 Years
FEMALE
No
Sponsors
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MDX Research
NETWORK
Perfect Care Distribution
INDUSTRY
Responsible Party
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Principal Investigators
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Ema Peta
Role: STUDY_DIRECTOR
Perfect Care Distribution
Locations
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Spitalul Clinic Dr. Ion Cantacuzino Bucharest
Bucharest, , Romania
Med Life Humanitas Cluj-Napoca
Cluj-Napoca, , Romania
Cabinet Medical - Dr. Saleh K. Majed
Craiova, , Romania
Cabinet Medical - Dr. Surpanelu Oana
Iași, , Romania
MediBlue
Iași, , Romania
Clinica Natisan Pitesti
Piteşti, , Romania
Cabinet Dr. Rădulescu G. Mihaela Elena
Râmnicu Vâlcea, , Romania
Ramnicu Valcea
Râmnicu Vâlcea, , Romania
Cabinet Ginecologic Dr. Popescu Sibiu
Sibiu, , Romania
Clinica iMED
Sibiu, , Romania
Pan Medical Sibiu
Sibiu, , Romania
Bradmed SRL
Târgu Jiu, , Romania
Cabinet Dr. Ioana Trotea Targu Jiu
Târgu Jiu, , Romania
Clinica Medicala Dr. Cioata Ionel Trifon
Timișoara, , Romania
Spitalul Judetean de Urgenta Tulcea
Tulcea, , Romania
Countries
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References
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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.
Other Identifiers
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CYRONRW/02/2022
Identifier Type: -
Identifier Source: org_study_id