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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT04735718
Recruitment Status : Completed
First Posted : February 3, 2021
Last Update Posted : January 20, 2023
MDX Research
Information provided by (Responsible Party):
Perfect Care Distribution

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.

Condition or disease Intervention/treatment Phase
Cervical Lesion Device: Cerviron Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: A Prospective, Open-Label, Pilot, Multicentric Clinical Investigation
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective, Open-Label, Pilot, Multicentric Clinical Investigation to Evaluate the Performance and Safety of Cerviron® Ovules in Cervix Lesions Postoperative Care
Actual Study Start Date : August 1, 2021
Actual Primary Completion Date : January 6, 2023
Actual Study Completion Date : January 16, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: After Surgery

Arm Intervention/treatment
Experimental: Cerviron vaginal ovules
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

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.

Primary Outcome Measures :
  1. Clinical Performance Assessed by the Investigator by Colposcopy at End of Treatment Visit [ Time Frame: 3 months ]
    Evolution of cervical lesions at End of Treatment Visit

  2. Rate of treatment-related Adverse Events in subjects participating in the clinical investigation [ Time Frame: 3 months ]
    Number and degree of AE

Secondary Outcome Measures :
  1. The Re-epithelialization degree of the cervical mucosa by thorough gynaecological examination (visual evaluation) [ Time Frame: at 1, 2 and 3 months ]
    Gynecological examination by speculum at 1, 2 and 3 months

  2. Evolution of vaginal symptoms and discomfort [ Time Frame: at 1, 2 and 3 months ]
    Presence/absence of symptoms such as pain and/or bleeding at 1, 2 and 3 months

  3. Patient Satisfaction (Likert Scale) [ Time Frame: 3 months ]
    5 point Likert scale to evaluate the degree of satisfaction after the treatment

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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 Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04735718

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Institutul National pentru Sanatatea Mamei si Copilului " Alessandrescu-Rusescu"
Bucharest, Romania
Centrul Medical MIȘCĂ
Timisoara, Romania
Spitalul Clinic Județean de Urgență "Pius Brinzeu"
Timisoara, Romania
Sponsors and Collaborators
Perfect Care Distribution
MDX Research
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Study Director: Ramona Petrita, CSO MDX Research
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Responsible Party: Perfect Care Distribution
ClinicalTrials.gov Identifier: NCT04735718    
Other Study ID Numbers: CYRON/02/2021
First Posted: February 3, 2021    Key Record Dates
Last Update Posted: January 20, 2023
Last Verified: January 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Perfect Care Distribution:
cervical lesion
Additional relevant MeSH terms:
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Uterine Cervical Diseases
Uterine Diseases