Evaluate Formation of IUAs After Third-generation Endometrial Ablation, With and Without Intrauterine Adhesion Barrier

NACompletedINTERVENTIONAL
Enrollment

1

Participants

Timeline

Start Date

November 11, 2022

Primary Completion Date

February 5, 2024

Study Completion Date

February 5, 2024

Conditions
Asherman SyndromeIntrauterine Adhesion
Interventions
DEVICE

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.

Trial Locations (2)

5623EJ

Catharina Hospital, Eindhoven

6001BE

St. Jans Gasthuis, Weert

All Listed Sponsors
lead

Remko P. Bosgraaf

OTHER