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

NCT04735718 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2023-01-20

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • MDX Research

    collaborator NETWORK

  • Perfect Care Distribution

    lead INDUSTRY

Principal Investigators

  • Ramona Petrita, CSO · MDX Research

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-08-01
Primary Completion
2023-01-06
Completion
2023-01-16

Countries

  • Romania

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04735718 on ClinicalTrials.gov