Clinical trial NCT05668806: RWE Study in the Treatment of Cervical Lesions of Various Etiology
Official title: Study of Real-world Evidence in Patients Treated With Cerviron Vaginal Ovules in the Treatment of Cervical Lesions of Various Etiology
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cervical Lesion
Vaginal Bleeding
Keywords: cervical ectropion
vaginal discharge
cervix lesion
Lead sponsor: Perfect Care Distribution
Sponsor class: INDUSTRY
Collaborators: name: MDX Research
First posted: 2022-12-30
Enrollment: 345
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Rate of treatment-related adverse events in subjects participating in the clinical investigation
timeFrame: 3 months
Secondary outcomes:
measure: Clinical Performance assessed by the investigator
timeFrame: 3 months
measure: Patient Satisfaction
timeFrame: 3 months
Other outcomes:
Locations:
city: Bucharest
country: Romania
facility: Spitalul Clinic Dr. Ion Cantacuzino Bucharest
city: Cluj-Napoca
country: Romania
facility: Med Life Humanitas Cluj-Napoca
city: Craiova
country: Romania
facility: Cabinet Medical - Dr. Saleh K. Majed
city: Iaşi
country: Romania
facility: Cabinet Medical - Dr. Surpanelu Oana
city: Iaşi
country: Romania
facility: MediBlue
city: Piteşti
country: Romania
facility: Clinica Natisan Pitesti
city: Râmnicu Vâlcea
country: Romania
facility: Cabinet Dr. Rădulescu G. Mihaela Elena
city: Râmnicu Vâlcea
country: Romania
facility: Ramnicu Valcea
city: Sibiu
country: Romania
facility: Cabinet Ginecologic Dr. Popescu Sibiu
city: Sibiu
country: Romania
facility: Clinica iMED
city: Sibiu
country: Romania
facility: Pan Medical Sibiu
city: Timişoara
country: Romania
facility: Clinica Medicala Dr. Cioata Ionel Trifon
city: Tulcea
country: Romania
facility: Spitalul Judetean de Urgenta Tulcea
city: Târgu Jiu
country: Romania
facility: Bradmed SRL
city: Târgu Jiu
country: Romania
facility: Cabinet Dr. Ioana Trotea Targu Jiu
Study officials:
affiliation: Perfect Care Distribution
name: Ema Peta
role: STUDY_DIRECTOR
References: