RWE Study in the Treatment of Cervical Lesions of Various Etiology

Perfect Care Distribution

Status: Completed

Conditions: Vaginal Bleeding; Cervical Lesion

Treatments: Device: Cerviron

Study type: Observational

Funder types: NETWORK; Industry

Identifiers

NCT05668806

CYRONRW/02/2022

Details and patient eligibility

About

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.

Full 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.

Enrollment: 345 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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