RWE Study in the Treatment of Cervical Lesions of Various Etiology

Sponsor

Perfect Care Distribution (Industry)

Overall Status

Completed

CT.gov ID

NCT05668806

Collaborator

MDX Research (Other)

345

Enrollment

Locations

2.4

Actual Duration (Months)

Patients Per Site

9.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cervical Lesion Vaginal Bleeding	Device: Cerviron

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 Design

Study Type:

Observational

Actual Enrollment :

345 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

May 20, 2021

Actual Primary Completion Date :

Jul 31, 2021

Actual Study Completion Date :

Jul 31, 2021

Outcome Measures

Primary Outcome Measures

Rate of treatment-related adverse events in subjects participating in the clinical investigation [3 months]
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0

Secondary Outcome Measures

Clinical Performance assessed by the investigator [3 months]
An assessment of the cervical lesions by gynecological examination (visual evaluation)
Patient Satisfaction [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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

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

Contacts and Locations

Locations

	Site	City	Country
1	Spitalul Clinic Dr. Ion Cantacuzino Bucharest	Bucharest	Romania
2	Med Life Humanitas Cluj-Napoca	Cluj-Napoca	Romania
3	Cabinet Medical - Dr. Saleh K. Majed	Craiova	Romania
4	Cabinet Medical - Dr. Surpanelu Oana	Iaşi	Romania
5	MediBlue	Iaşi	Romania
6	Clinica Natisan Pitesti	Piteşti	Romania
7	Cabinet Dr. Rădulescu G. Mihaela Elena	Râmnicu Vâlcea	Romania
8	Ramnicu Valcea	Râmnicu Vâlcea	Romania
9	Cabinet Ginecologic Dr. Popescu Sibiu	Sibiu	Romania
10	Clinica iMED	Sibiu	Romania
11	Pan Medical Sibiu	Sibiu	Romania
12	Clinica Medicala Dr. Cioata Ionel Trifon	Timişoara	Romania
13	Spitalul Judetean de Urgenta Tulcea	Tulcea	Romania
14	Bradmed SRL	Târgu Jiu	Romania
15	Cabinet Dr. Ioana Trotea Targu Jiu	Târgu Jiu	Romania