RWE Study in the Treatment of Cervical Lesions of Various Etiology

NCT05668806 | Completed

• 1 other identifier: CYRONRW/02/2022
• Study Type: observational
• Target: 345
• Locations: 1 country
• Sites: 15

Brief 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

Keywords

cervical ectropion; vaginal discharge; cervix lesion

Outcome Measures

Primary Outcomes (1)

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

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

  3 months

Secondary Outcomes (2)

• Clinical Performance assessed by the investigator

  3 months

• Patient Satisfaction

  3 months

Interventions

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.

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Women who are taking oral contraceptives often have cervical ectopy (cervical erosions).
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• Patients with cervical cancer.
• Patients with vulvar cancer

Sponsors & Collaborators

• Perfect Care Distribution: lead
• MDX Research: collaborator

Study Sites (15)

Spitalul Clinic Dr. Ion Cantacuzino Bucharest

Bucharest, Romania

Location

Med Life Humanitas Cluj-Napoca

Cluj-Napoca, Romania

Location

Cabinet Medical - Dr. Saleh K. Majed

Craiova, Romania

Location

Cabinet Medical - Dr. Surpanelu Oana

Iași, Romania

Location

MediBlue

Iași, Romania

Location

Clinica Natisan Pitesti

Piteşti, Romania

Location

Cabinet Dr. Rădulescu G. Mihaela Elena

Râmnicu Vâlcea, Romania

Location

Ramnicu Valcea

Râmnicu Vâlcea, Romania

Location

Cabinet Ginecologic Dr. Popescu Sibiu

Sibiu, Romania

Location

Clinica iMED

Sibiu, Romania

Location

Pan Medical Sibiu

Sibiu, Romania

Location

Bradmed SRL

Târgu Jiu, Romania

Location

Cabinet Dr. Ioana Trotea Targu Jiu

Târgu Jiu, Romania

Location

Clinica Medicala Dr. Cioata Ionel Trifon

Timișoara, Romania

Location

Spitalul Judetean de Urgenta Tulcea

Tulcea, Romania

Location

Related Publications (1)

• 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.

  PMID: 37546352 DERIVED

MeSH Terms

Conditions

Uterine Hemorrhage; Vaginal Discharge

Condition Hierarchy (Ancestors)

Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Vaginal Diseases

Study Officials

• Ema Peta

  Perfect Care Distribution

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2022
• First Posted: December 30, 2022
• Study Start: May 20, 2021
• Primary Completion: July 31, 2021
• Study Completion: July 31, 2021
• Last Updated: December 30, 2022

Record last verified: 2022-12

Locations

RO (15)