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

NCT06585579 | Not Yet Recruiting

• 2 other identifiers: MUCO2322022-A02640-43
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 3

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

Outcome Measures

Primary Outcomes (1)

• To confirm the performance of Mucogyne® ovule in wound healing promotion

  The primary endpoint is a composite endpoint derived with the following criteria: * Inflammation evaluated with a 5-point scale (none, mild, moderate, severe, very severe) and not assessed, * Edema evaluated with a 5-point scale (none, mild, moderate, severe, very severe) and not assessed, * Abrasion evaluated with a 5-point scale (none, mild, moderate, severe, very severe) and not assessed, * Coalescence evaluated with a 3-point scale (none, partial, total) and not assessed. * Opening of the cervix (only for cervical wound) evaluated with a 4-point scale (closed, slightly open, open, gaping) and not assessed.

  Day 0 to day 21(+10)

Secondary Outcomes (6)

• To assess the aspect of the epithelium 3(+1) weeks after surgery

  Day 0 to day 21(+10)

• To assess the performance of Mucogyne® ovule in symptoms relief

  Day 0 to day 21(+10)

• To assess the performance of Mucogyne® ovule in reducing postoperative side effects and complications

  Day 0 to day 21(+10)

• To assess change in clinical status

  Day 0 to day 21(+10)

• To assess compliance with the Medical Device use

  Day 0 to day 21(+10)

Study Arms (2)

Mucogyne group

EXPERIMENTAL

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)

Device: Mucogyne Ovule

Control group

NO INTERVENTION

standard of care e.i no treatment

Interventions

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)

Mucogyne group

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Known hypersensitivity to any of the medical device ingredients,
• Patient with local infectious lesions in the area to be repaired.
• 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.

Sponsors & Collaborators

• Biocodex: lead

Study Sites (3)

CHU Amiens-Picardie

Amiens, 80054, France

Location

CHU Besançon

Besançon, 25000, France

Location

Hôpital Nord Franche-Comté

Trévenans, 90400, France

Location

Study Officials

• Oana BERNARD, MD

  Chief Scientific Officer

  STUDY DIRECTOR

Central Study Contacts

Gaëlle MARIAULE

CONTACT

+33 3 44 86 75 97; g.mariaule@biocodex.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: prospective, multicenter, randomized, controlled study

Study Record Dates

• First Submitted: September 3, 2024
• First Posted: September 5, 2024
• Study Start: October 1, 2024
• Primary Completion: August 1, 2025
• Study Completion: November 1, 2025
• Last Updated: September 5, 2024

Record last verified: 2024-09

Locations

FR (3)