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| ID | Type | Description | Link |
|---|---|---|---|
| 2022-A02640-43 | Other Identifier | ID-RCB |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mucogyne group | Experimental | For each eligible patient, the study will consist of:
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| Control group | No Intervention | standard of care e.i no treatment |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mucogyne Ovule | Device | In Mucogyne group, patient will receive 2 boxes of Mucogyne® ovule. 24 hours after intervention, the patient will apply Mucogyne® ovule, 1 ovule per day for 10 days, to be repeated as needed (for practices' homogenisation, after the 10th day, it is recommended to apply one ovule every second day, until EOS visit) |
| Measure | Description | Time Frame |
|---|---|---|
| To confirm the performance of Mucogyne® ovule in wound healing promotion | The primary endpoint is a composite endpoint derived with the following criteria:
| Day 0 to day 21(+10) |
| Measure | Description | Time Frame |
|---|---|---|
| To assess the aspect of the epithelium 3(+1) weeks after surgery | Criteria assessing the aspect of the epithelium (such as presence of mucosa, stroma, presence and quality of mucus, opening of the cervix, presence or absence of inflammation, edema, vulvo-vaginal abrasions, coalescence, adherence, leucorrhoea and bleeding at contact) | Day 0 to day 21(+10) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gaëlle MARIAULE | Contact | +33 3 44 86 75 97 | g.mariaule@biocodex.fr |
| Name | Affiliation | Role |
|---|---|---|
| Oana BERNARD, MD | Chief Scientific Officer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Amiens-Picardie | Amiens | 80054 | France |
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prospective, multicenter, randomized, controlled study
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| To assess the performance of Mucogyne® ovule in symptoms relief | Vaginal symptoms (dryness, itching, burning, discharge) will be assessed by the patient using a 4-point scale (1 = absent, 2 = mild, 3 = moderate, 4 = severe) at 3 (+1) weeks after surgery | Day 0 to day 21(+10) |
| To assess the performance of Mucogyne® ovule in reducing postoperative side effects and complications | Postoperative side-effects (i.e. postoperative bleeding, infection and impairment of daily activities, etc.) will be assessed using a questionnaire. For the assessment of hemorrhage, the amounts of bleeding will be checked with a pictorial blood assessment chart. | Day 0 to day 21(+10) |
| To assess change in clinical status | Change in clinical status will be assessed by the Investigator using Clinical Global Impressions scale, (CGI) at 3(+1) weeks after surgery | Day 0 to day 21(+10) |
| To assess compliance with the Medical Device use | Compliance with the Medical Device use will be assessed by number of days of use | Day 0 to day 21(+10) |
| To assess the safety of Mucogyne® ovule | Number, nature and characteristics of any incident reported: incidence, seriousness, severity, resolution | Day 0 to day 21(+10) |
| CHU Besançon | Besançon | 25000 | France |
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| Hôpital Nord Franche-Comté | Trévenans | 90400 | France |
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