The Efficacy and Safety of Medicurtain® in Patients With Hysteroscopy (Pivotal Study)
Condition: Intrauterine Synechiae; Tissue Adhesion, Surgery-Induced
MeSH terms: Gynatresia; Tissue Adhesions
Study type: Interventional

Summary: 
      This study was designed to assess the safety and efficacy of MEDICURTAIN, an adhesion barrier
      in patients who underwent hysteroscopy with uterine polyp or endometrial myoma or missed
      abortion (uterine lesion suspected to be associated with pregnancy) or intrauterine adhesion.
      Adhesion formation in both groups was evaluated by the grading scale and photographs taken
      during the follow up to evaluate the safety and efficacy of the product.
    

Detailed description: 
      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.
    

Intervention name(s): Medicurtain®; Placebo
Intervention type(s): Device; Device
Intervention description(s): Anti-adhesion barrier (Medicurtain® 5ml prefilled syringe after hysteroscopy surgery); No device after hysteroscopy surgery
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Pivotal study (Determine effectiveness and adverse effects)
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Medicurtain; Sodium hyaluronate; Anti-adhesion barrier