RWE Study in the Treatment of Cervical Lesions of Various Etiology

December 24, 2022 updated by: Perfect Care Distribution

Study of Real-world Evidence in Patients Treated With Cerviron Vaginal Ovules 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

345

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Romania
      • Bucharest, Romania
        • Spitalul Clinic Dr. Ion Cantacuzino Bucharest
      • Cluj-Napoca, Romania
        • Med Life Humanitas Cluj-Napoca
      • Craiova, Romania
        • Cabinet Medical - Dr. Saleh K. Majed
      • Iaşi, Romania
        • Cabinet Medical - Dr. Surpanelu Oana
      • Iaşi, Romania
        • MediBlue
      • Piteşti, Romania
        • Clinica Natisan Pitesti
      • Râmnicu Vâlcea, Romania
        • Cabinet Dr. Rădulescu G. Mihaela Elena
      • Râmnicu Vâlcea, Romania
        • Ramnicu Valcea
      • Sibiu, Romania
        • Pan Medical Sibiu
      • Sibiu, Romania
        • Cabinet Ginecologic Dr. Popescu Sibiu
      • Sibiu, Romania
        • Clinica iMED
      • Timişoara, Romania
        • Clinica Medicala Dr. Cioata Ionel Trifon
      • Tulcea, Romania
        • Spitalul Judetean de Urgenta Tulcea
      • Târgu Jiu, Romania
        • Cabinet Dr. Ioana Trotea Targu Jiu
      • Târgu Jiu, Romania
        • Bradmed SRL

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

Women aged above 18 years with a clearly diagnosed non-infectious gynecological disease and patients with traumatic or surgical lesions.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical Performance assessed by the investigator
Time Frame: 3 months
An assessment of the cervical lesions by gynecological examination (visual evaluation)
3 months
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).
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Perfect Care Distribution

Collaborators

MDX Research

Investigators

  • Study Director: Ema Peta, Perfect Care Distribution

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 20, 2021

Primary Completion (Actual)

July 31, 2021

Study Completion (Actual)

July 31, 2021

Study Registration Dates

First Submitted

November 18, 2022

First Submitted That Met QC Criteria

December 24, 2022

First Posted (Actual)

December 30, 2022

Study Record Updates

Last Update Posted (Actual)

December 30, 2022

Last Update Submitted That Met QC Criteria

December 24, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CYRONRW/02/2022

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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