RWE Study in the Treatment of Cervical Lesions of Various Etiology

CompletedOBSERVATIONAL
Enrollment

345

Participants

Timeline

Start Date

May 20, 2021

Primary Completion Date

July 31, 2021

Study Completion Date

July 31, 2021

Conditions
Cervical LesionVaginal Bleeding
Interventions
DEVICE

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.

Trial Locations (15)

Unknown

Spitalul Clinic Dr. Ion Cantacuzino Bucharest, Bucharest

Med Life Humanitas Cluj-Napoca, Cluj-Napoca

Cabinet Medical - Dr. Saleh K. Majed, Craiova

Cabinet Medical - Dr. Surpanelu Oana, Iași

MediBlue, Iași

Clinica Natisan Pitesti, Piteşti

Cabinet Dr. Rădulescu G. Mihaela Elena, Râmnicu Vâlcea

Ramnicu Valcea, Râmnicu Vâlcea

Cabinet Ginecologic Dr. Popescu Sibiu, Sibiu

Clinica iMED, Sibiu

Pan Medical Sibiu, Sibiu

Bradmed SRL, Târgu Jiu

Cabinet Dr. Ioana Trotea Targu Jiu, Târgu Jiu

Clinica Medicala Dr. Cioata Ionel Trifon, Timișoara

Spitalul Judetean de Urgenta Tulcea, Tulcea

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

MDX Research

NETWORK

lead

Perfect Care Distribution

INDUSTRY

NCT05668806 - RWE Study in the Treatment of Cervical Lesions of Various Etiology | Biotech Hunter | Biotech Hunter