Safety and efficacy of a novel barrier film to prevent intrauterine adhesion formation after hysteroscopic myomectomy: The PREG1 clinical trial.

Abstract

OBJECTIVE\nTo evaluate the safety and potential efficacy of a novel degradable polymer film (DPF), designed to act as a 7-day barrier to prevent intrauterine adhesions (IUAs), post hysteroscopic myomectomy.\n\n\nDESIGN\nA prospective single arm, first-in-human clinical study.\n\n\nSETTING\nMulticenter study involving 6 centers in France, Belgium and the Netherlands Patients: Women ≥40 years with no plans to conceive who qualified for hysteroscopic myomectomy (at least one 10 millimeter type 0, 1 or 2 myoma) and had a sounded length of the uterine cavity (fundus to exocervix) ranging between 6 - 9 cm, were considered eligible for the study.\n\n\nINTERVENTIONS\nThe DPF was inserted following hysteroscopic transcervical myoma resection. Women were followed up by a telephone call at 30 days and a second look hysteroscopy 4-8 weeks post procedure.\n\n\nMEASUREMENTS AND MAIN RESULTS\nThe chosen safety outcome measures were uterine perforation or cervical trauma at the time of the DPF insertion and unexpected fever, pain or bleeding beyond 48 hours and up to 30 days post insertion, while the outcome measure for efficacy was the absence of adhesions on second look hysteroscopy. A total of 23 women participated in the study. There were no incidents of uterine perforation or cervical trauma at the time of the DPF insertion. There were no reported side effects attributable to the film. On second look hysteroscopy, 20 of 23 (87%) women had no intrauterine adhesions.\n\n\nCONCLUSION\nThe degradable polymer film is a novel, easy to apply and acceptable device for intrauterine adhesion prevention with very promising initial safety and efficacy data.