Clinical Investigation To Evaluate Cerviron Ovules® in Cervix Lesions Postoperative Care

NCT04735718 | Completed

• 1 other identifier: CYRON/02/2021
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 3

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 to assess the therapeutic performance and tolerability of Cerviron® Ovules in postoperative care in patients that underwent surgical removal of benign, cervical lesions. 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.

Conditions

Cervical Lesion

Keywords

cervical lesion

Outcome Measures

Primary Outcomes (2)

• Clinical Performance Assessed by the Investigator by Colposcopy at End of Treatment Visit

  Evolution of cervical lesions at End of Treatment Visit

  3 months

• Rate of treatment-related Adverse Events in subjects participating in the clinical investigation

  Number and degree of AE

  3 months

Secondary Outcomes (3)

• The Re-epithelialization degree of the cervical mucosa by thorough gynaecological examination (visual evaluation)

  at 1, 2 and 3 months

• Evolution of vaginal symptoms and discomfort

  at 1, 2 and 3 months

• Patient Satisfaction (Likert Scale)

  3 months

Study Arms (1)

Cerviron vaginal ovules

EXPERIMENTAL

Since Cerviron® has an innovative composition, we preferred an exploratory approach for the design of the present clinical investigation. The main objectives and clinical endpoints are the performance and the safety profile of the investigational device.

Device: Cerviron

Interventions

Cerviron DEVICE

Cerviron® ovules is a class IIb medical device used as adjuvant treatment in cervical lesions of mechanical origin. It favors the healing and re-epithelialization processes and reduces the proliferation of endogenous pathogens. Moreover, it provides a strong hemostatic effect, as shown in multiple studies. Moreover, it contains collagen with nutritive, hydrating, healing and trophic effect. Collagen is structurally and functionally a key protein of the extracellular matrix which is also involved in forming the scars during the healing of conjunctive tissues, due to its chemotactic role. Many collagen bandages were developed to improve the repair of the wound, especially of non-infected, chronic, idle cutaneous ulcerations.

Cerviron vaginal ovules

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Perfect Care Distribution: lead
• MDX Research: collaborator

Study Sites (3)

Institutul National pentru Sanatatea Mamei si Copilului " Alessandrescu-Rusescu"

Bucharest, Romania

Location

Centrul Medical MIȘCĂ

Timișoara, Romania

Location

Spitalul Clinic Județean de Urgență "Pius Brinzeu"

Timișoara, Romania

Location

Related Publications (1)

• Petre I, Toader DO, Petrita R, Pinta AR, Alexa AA, Bita RG. Clinical Performance and Safety of Cerviron(R) Vaginal Ovules in the Management of Symptomatic Cervical Lesions: A National, Multicentric Study. Curr Ther Res Clin Exp. 2024 Oct 9;101:100762. doi: 10.1016/j.curtheres.2024.100762. eCollection 2024.

  PMID: 39717511 DERIVED

Study Officials

• Ramona Petrita, CSO

  MDX Research

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: A Prospective, Open-Label, Pilot, Multicentric Clinical Investigation

Study Record Dates

• First Submitted: January 29, 2021
• First Posted: February 3, 2021
• Study Start: August 1, 2021
• Primary Completion: January 6, 2023
• Study Completion: January 16, 2023
• Last Updated: January 20, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

RO (3)