Safety & Efficacy of Womed Leaf™, a Novel Barrier Film to Prevent Intrauterine Adhesions after Hysteroscopic Myomectomy: The PREG1 Trial.

Study Objective The objective of this first-in-human study was to evaluate the safety of the novel intrauterine adhesion barrier film Womed LeafTM and pilot its potential efficacy in preventing IUAs after hysteroscopic myomectomy. Design PREG1 is a prospective, multi-center, international, single arm clinical study. Womed LeafTM (Womed SAS, France) is a degradable polymer film (DPF) designed for insertion into the uterus like an IUD, that self-expands to fill the cavity and separate the uterine walls. After approximately one week, it degrades to be naturally discharged through the cervix. The safety endpoint was the number of device-related Adverse Events (AE) at thirty days, and the efficacy endpoint was freedom from IUA at second look hysteroscopy at six weeks. Setting N/A. Patients or Participants 23 women over 40 years with no plans to conceive who qualified for transcervical resection of myoma (TCRM), with at least one 10=millimeter type 0, 1 or 2 myoma, were enrolled between December 2019 and January 2021, from six centers in France, Belgium and the Netherlands. Interventions Women underwent TCRM, immediately followed by DPF insertion and ultrasound verification. Measurements and Main Results The device was successfully delivered on first attempt in all cases and the procedure was rated as easy by all operators. The DPF was visible by ultrasound in 22/23 women (96%). There were no device-related AE. Of the 23 women, 13 noticed the DPF discharge 6 days on average after surgery, with a discomfort level of 1.9 on a scale of 10. At second look hysteroscopy, 20 of the 23 women (87%) were free of IUAs, and no residual DPF was found in the uterine cavity. Conclusion Womed LeafTM, the first mechanical barrier specifically designed to prevent IUA, is a novel, safe, easy to apply device with very promising initial efficacy data. The objective of this first-in-human study was to evaluate the safety of the novel intrauterine adhesion barrier film Womed LeafTM and pilot its potential efficacy in preventing IUAs after hysteroscopic myomectomy. PREG1 is a prospective, multi-center, international, single arm clinical study. Womed LeafTM (Womed SAS, France) is a degradable polymer film (DPF) designed for insertion into the uterus like an IUD, that self-expands to fill the cavity and separate the uterine walls. After approximately one week, it degrades to be naturally discharged through the cervix. The safety endpoint was the number of device-related Adverse Events (AE) at thirty days, and the efficacy endpoint was freedom from IUA at second look hysteroscopy at six weeks. N/A. 23 women over 40 years with no plans to conceive who qualified for transcervical resection of myoma (TCRM), with at least one 10=millimeter type 0, 1 or 2 myoma, were enrolled between December 2019 and January 2021, from six centers in France, Belgium and the Netherlands. Women underwent TCRM, immediately followed by DPF insertion and ultrasound verification. The device was successfully delivered on first attempt in all cases and the procedure was rated as easy by all operators. The DPF was visible by ultrasound in 22/23 women (96%). There were no device-related AE. Of the 23 women, 13 noticed the DPF discharge 6 days on average after surgery, with a discomfort level of 1.9 on a scale of 10. At second look hysteroscopy, 20 of the 23 women (87%) were free of IUAs, and no residual DPF was found in the uterine cavity. Womed LeafTM, the first mechanical barrier specifically designed to prevent IUA, is a novel, safe, easy to apply device with very promising initial efficacy data.