The Effect of Mucogyne® Ovule on Wound Healing (ORIGYNE) (NCT06585579) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
The Effect of Mucogyne® Ovule on Wound Healing (ORIGYNE)
France144 participantsStarted 2024-10
Plain-language 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 used in accordance with its approved labelling, in the context of local cervicovaginal surgery.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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 criteria
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
To confirm the performance of Mucogyne® ovule in wound healing promotion
. 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,