Status:
NOT_YET_RECRUITING
The Effect of Mucogyne® Ovule on Wound Healing (ORIGYNE)
Lead Sponsor:
Biocodex
Conditions:
Cervicovaginitis
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
This clinical investigation is a post-market clinical follow-up performed to confirm the performance and safety of the Mucogyne® ovule medical device in promoting the process of wound healing, when us...
Eligibility Criteria
Inclusion
- Adult women who had undergone localized surgery (laser or loop electrosurgical excision procedure (LEEP) conization) for cervical or vaginal dysplasia,
- Is able to understand the study related information and to give a written informed consent,
- Has signed the informed consent form before beginning any study procedure,
- Has no condition that may interfere with the study assessments,
- Agrees not to use other vaginal products than those planned in the study protocol, during participation in the study,
- Is able to comply with protocol requirements and respect the conditions of the study,
- Affiliated to the Social Security system.
Exclusion
- Previous vaginal surgery within the year preceding the inclusion in the study,
- Known hypersensitivity to any of the medical device ingredients,
- Patient with local infectious lesions in the area to be repaired.
- Patient who had used anti-inflammatory drugs (regular intake) or anticoagulants during the month preceding the inclusion in the study,
- Patient who had a history of diseases known to disturb wound healing (e.g. systemic, heart, and renal diseases, coagulation disorders, immunedeficiency, connective tissue disorders, diabetes, anemia (with hemoglobin level \< 9 g/dl) and hemophilia),
- Immunosuppressive treatment,
- Heavy cigarettes smoker (i.e., more than 15 cigarettes or equivalent/day, according to the patient and their documented records),
- Patients under judicial protection or under guardianship and patients deprived of freedom,
- Has any other severe chronic or acute medical or psychiatric condition that in the judgment of the Investigator, could interfere with the study assessments.
Key Trial Info
Start Date :
October 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2025
Estimated Enrollment :
144 Patients enrolled
Trial Details
Trial ID
NCT06585579
Start Date
October 1 2024
End Date
November 1 2025
Last Update
September 5 2024
Active Locations (3)
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1
CHU Amiens-Picardie
Amiens, France, 80054
2
CHU Besançon
Besançon, France, 25000
3
Hôpital Nord Franche-Comté
Trévenans, France, 90400