Status:
COMPLETED
Clinical Investigation To Evaluate Cerviron Ovules® in Cervix Lesions Postoperative Care
Lead Sponsor:
Perfect Care Distribution
Collaborating Sponsors:
MDX Research
Conditions:
Cervical Lesion
Eligibility:
FEMALE
18-65 years
Phase:
NA
Brief Summary
CYRON is a Prospective, Open-Label, Pilot, Multicentric Clinical Investigation to Evaluate the Performance and Safety of Cerviron® Ovules in Cervix Lesions Postoperative Care. The primary objective is...
Detailed Description
Identifying premalignant and benign diseases of the cervix and selecting an appropriate treatment path can be challenging. The adult uterine cervix may exhibit a wide variety of pathologic conditions ...
Eligibility Criteria
Inclusion
- Adult females, aged 18 years to 65 years;
- Subjects presenting benign, ectopic, cervix lesions that were excised no later than 7 days before the Screening Visit, confirmed by colposcopy;
- Subjects presenting a normal cervical cytology report, e.g. Negative for Intraepithelial Lesions or Malignancy (NILM) or slightly modified to Atypical Squamous Cells of Undetermined Significance (ASC-US) in the last 6 months;
- Subjects willing to provide signed informed consent to clinical investigation participation.
Exclusion
- Previous history of any malignancy, particularly those that are prone to metastases, including breast, melanoma, gestational trophoblastic disease, and high-grade malignancies of the gastrointestinal tract or lung;
- Subjects with undiagnosed abnormal genital bleeding;
- Subject with vulvar, vaginal or cervical cancer;
- Subjects presenting an abnormal cytology report, e.g. cervical intraepithelial neoplasia" (CIN) or "adenocarcinoma in situ" (AIS) in the last 6 months;
- Watery or foul discharge;
- Subjects with HIV or other immunodeficiency;
- Use of spermicides;
- Use of diaphragm;
- Concomitant topical or systemic anti-infective treatment;
- Unable to comply with visit procedures;
- Subjects included in other clinical investigations with similar objectives
Key Trial Info
Start Date :
August 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 16 2023
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT04735718
Start Date
August 1 2021
End Date
January 16 2023
Last Update
January 20 2023
Active Locations (3)
Enter a location and click search to find clinical trials sorted by distance.
1
Institutul National pentru Sanatatea Mamei si Copilului " Alessandrescu-Rusescu"
Bucharest, Romania
2
Centrul Medical MIȘCĂ
Timișoara, Romania
3
Spitalul Clinic Județean de Urgență "Pius Brinzeu"
Timișoara, Romania