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

NCT06585579 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 144

Last updated 2024-09-05

No results posted yet for this study

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

Interventions

DEVICE

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)

Sponsors & Collaborators

  • Biocodex

    lead INDUSTRY

Principal Investigators

  • Oana BERNARD, MD · Chief Scientific Officer

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-31
Primary Completion
2025-08-31
Completion
2025-11-30

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06585579 on ClinicalTrials.gov