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Completed

NCT Number: NCT05668806

RWE Study in the Treatment of Cervical Lesions of Various Etiology

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.

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Key information

Conditions

Cervical Lesion Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Hemorrhage Pathologic Processes Pathological Conditions, Signs and Symptoms Urogenital Diseases Uterine Diseases Uterine Hemorrhage Vaginal Bleeding Vaginal Discharge Vaginal Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Spitalul Clinic Dr. Ion Cantacuzino Bucharest, Bucharest, Romania

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About this study

This study is an observational, post-marketing study conducted between May-July 2021.

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with a clearly diagnosed non-infectious gynecological disease and patients with traumatic or surgical lesions.
  • 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 cervical cancer.
  • Patients with vulvar cancer

Treatment and study plan

Cerviron

Device

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.

Primary outcomes

  1. Rate of treatment-related adverse events in subjects participating in the clinical investigation

    Time frame: 3 months

    Number of participants with treatment-related adverse events as assessed by CTCAE v5.0

Secondary outcomes

  1. Clinical Performance assessed by the investigator

    Time frame: 3 months

    An assessment of the cervical lesions by gynecological examination (visual evaluation)

  2. Patient Satisfaction

    Time frame: 3 months

    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).

Sponsors and collaborators

Lead sponsor

Perfect Care Distribution

Industry

Collaborators

  • MDX Research

Registry information

Official study title

Study of Real-world Evidence in Patients Treated With Cerviron Vaginal Ovules in the Treatment of Cervical Lesions of Various Etiology

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Dec 30, 2022
Registry last updated
Dec 30, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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