1
Participants
Start Date
November 11, 2022
Primary Completion Date
February 5, 2024
Study Completion Date
February 5, 2024
Womed Leaf
Womed Leaf™ is a sterile, degradable film of poly(D,L-lactide) (PLA) and poly(ethylene oxide) (PEO). PEO is a biocompatible polymer with anti-adhesion and swelling properties. It is polymerized with hydrophobic PLA to form a degradable film. Womed Leaf™ is inserted in the uterine cavity by a gynaecologist surgeon with a 5 mm diameter flexible inserter. Once released, the film unfolds and grows into the uterine cavity to create a mechanical barrier and keep the uterine walls separated for approximately one week. It is then degraded and discharged naturally through the cervix.
Catharina Hospital, Eindhoven
St. Jans Gasthuis, Weert
Remko P. Bosgraaf
OTHER