The Effect of Mucogyne® Ovule on Wound Healing (ORIGYNE)

NCT ID: NCT06585579

Last Updated: 2024-09-05

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 144 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-31
• Study Completion Date: 2025-11-30

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 used in accordance with its approved labelling, in the context of local cervicovaginal surgery.

Conditions

Cervicovaginitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Mucogyne group

For each eligible patient, the study will consist of:

• A Screening/Inclusion visit
• A treatment period (application of the medical device Mucogyne® ovule) for 21 days
• An End Of Study visit (Day 21 (+10) after surgery)

Group Type: EXPERIMENTAL

Mucogyne Ovule

Intervention Type: 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)

Control group

standard of care e.i no treatment

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Mucogyne Ovule

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)

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Adult women who had undergone localized surgery (laser or loop electrosurgical excision procedure (LEEP) conization) for cervical or vaginal dysplasia,

2. Is able to understand the study related information and to give a written informed consent,

3. Has signed the informed consent form before beginning any study procedure,

4. Has no condition that may interfere with the study assessments,

5. Agrees not to use other vaginal products than those planned in the study protocol, during participation in the study,

6. Is able to comply with protocol requirements and respect the conditions of the study,

7. Affiliated to the Social Security system.

Exclusion Criteria

1. Previous vaginal surgery within the year preceding the inclusion in the study,

2. Known hypersensitivity to any of the medical device ingredients,

3. Patient with local infectious lesions in the area to be repaired.

4. Patient who had used anti-inflammatory drugs (regular intake) or anticoagulants during the month preceding the inclusion in the study,

5. 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),

6. Immunosuppressive treatment,

7. Heavy cigarettes smoker (i.e., more than 15 cigarettes or equivalent/day, according to the patient and their documented records),

8. Patients under judicial protection or under guardianship and patients deprived of freedom,

9. Has any other severe chronic or acute medical or psychiatric condition that in the judgment of the Investigator, could interfere with the study assessments.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Biocodex

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Oana BERNARD, MD

Role: STUDY_DIRECTOR

Chief Scientific Officer

Locations

CHU Amiens-Picardie

Amiens, , France

CHU Besançon

Besançon, , France

Hôpital Nord Franche-Comté

Trévenans, , France

Countries

France

Central Contacts

Gaëlle MARIAULE

Role: CONTACT

g.mariaule@biocodex.fr

+33 3 44 86 75 97

Facility Contacts

Arthur FOULON, MD

Role: primary

Rajeev RAMANAH, MD

Role: primary

Catherine GAY

Role: primary

Other Identifiers

2022-A02640-43

Identifier Type: OTHER

Identifier Source: secondary_id

MUCO232

Identifier Type: -

Identifier Source: org_study_id