Intrauterine adhesions (IUA) are the major long-term complication of intrauterine procedures and are associated with pelvic pain, menstrual disorders, obstetrical complication and infertility. Womed Leaf is a medical device specifically designed for intrauterine use that prevents intra-uterine adhesions. It is a film that acts as a mechanical barrier to keep uterus walls separated during healing. It is then naturally discharged through the cervix and vagina in less than 30 days. The PREG1 clinical investigation is designed to evaluate Womed Leaf safety under clinical conditions, in women scheduled for a hysteroscopic myomectomy as well as its efficacy.
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Safety (Adverse Events)
Timeframe: 30 days
Efficacy (Rate of Patient With no IUA)
Timeframe: At second look hysteroscopy between 4 and 8 weeks
Efficacy (Intrauterine Adhesion Severity According to AFS Classification)
Timeframe: At second look hysteroscopy between 4 and 8 weeks
Efficacy (Intrauterine Adhesion Severity According to ESGE Classification)
Timeframe: At second look hysteroscopy between 4 and 8 weeks