The Effect of Mucogyne® Ovule on Wound Healing (ORIGYNE)
ConditionCervicovaginitis
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorBiocodex
About this trial
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.
Eligibility criteria
Qualifiers
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,
Disqualifiers
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,
Trial design
Treatments tested in this trial
- Mucogyne Ovule
Treatment groups
144 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov