The Efficacy and Safety of Medicurtain® in Patients With Hysteroscopy (Pivotal Study)

This study was designed as a multi-center, randomized, evaluator-blinded and placebo-comparative study. A woman aged 20-80 years scheduled for the hysteroscopy was eligible to participate in the study. Subject screening was conducted for the subject who signed an informed consent form. Subjects who met the inclusion/exclusion criteria were randomly assigned into either treatment or no-treatment control group. Follow-up visits were performed at 1 week (Visit 2) and 4 weeks (Visit 3) after the index surgery. Telephone call is made between 1 to 2 weeks prior to the Visit 3 for the information for the follow-up visit and check-up. At Visit 2 (at Week 1 after the index surgery, a window of ± 2 days was allowed), assessments to identify adverse events and general health conditions, and surgery satisfaction survey were performed. At Visit 3 (at Week 4 ± 4 days), adverse event assessments and general satisfaction survey were performed, and adhesion formations and grades were evaluated. The presence or absence of adhesions, and their grades at Visit 3 (at Week 4 ± 4 days) were assessed in an evaluator-independent manner. Adhesion formations rate (Primary endpoint) and adhesion grade(secondary endpoint) were assessed at Week 4 after the index surgery (Visit 3), based on the video clips and still images captured via a video monitor during a second-look hysteroscopy, by inserting the hysteroscope (5 -10 mm diameter) into the uterine through the vagina; and graded in an evaluator-blinded manner by an independent evaluator, who did not take part in the index surgery or application of Medicurtain®. Intrauterine adhesion grades were assessed by using the American Fertility Society (AFS) adhesion score established in 1988. It was classified as 4 grading scales (0, 1, 2 and 3 grade). Grade 0 (none) means no adhesion, while Grade 1 to Grade 3 means there are adhesions and severity increased with the grade. Adhesion formation rate and grade in the treated or in the non-treated control groups were compared and evaluated using the Grade 0 to 3 adhesion scoring system.