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RWE Study in the Treatment of Cervical Lesions of Various Etiology

NCT05668806 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 345

Last updated 2022-12-30

No results posted yet for this study

Summary

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.

Conditions

  • Cervical Lesion
  • Vaginal 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.

Sponsors & Collaborators

  • MDX Research

    collaborator NETWORK

  • Perfect Care Distribution

    lead INDUSTRY

Principal Investigators

  • Ema Peta · Perfect Care Distribution

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-20
Primary Completion
2021-07-31
Completion
2021-07-31

Countries

  • Romania

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05668806 on ClinicalTrials.gov