RWE Study in the Treatment of Cervical Lesions of Various Etiology

Vaginal Bleeding Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05668806
• Other study ID #: CYRONRW/02/2022
• Status: Completed
• Start date: May 20, 2021
• Est. completion date: July 31, 2021

Study information

• Verified date: December 2022
• Source: Perfect Care Distribution
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 345
• Est. completion date: July 31, 2021
• Est. primary completion date: July 31, 2021
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cervical Lesion
• Uterine Cervical Diseases
• Uterine Hemorrhage
• Vaginal Bleeding

Intervention

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.

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Perfect Care Distribution	MDX Research

Country where clinical trial is conducted

Romania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Clinical Performance assessed by the investigator	An assessment of the cervical lesions by gynecological examination (visual evaluation)	3 months
Secondary	Patient Satisfaction	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