At a glance
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PREvention of Intrauterine Adhesion After Hysteroscopic Surgery With Novel deGradable Film
In Brief
A clinical study evaluating Womed Leaf for Intrauterine Adhesion. Completed, enrolled 23 participants across 6 sites in 3 countries.
Detailed Summary
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.
Study Details
Timeline
Interventions
Womed Leaf uterine film will be inserted immediately after the myomectomy, following per-operative hysterometry.