Pivotal Clinical Study to Assess the Anti-adhesive Effect and Safety of ABT13107 Applied to Postoperative Intrauterine
Not Applicable
Completed
- Conditions
- Postoperative Adhesion of Uterus
- Registration Number
- NCT04007211
- Lead Sponsor
- Medy-Tox
- Brief Summary
This study is intended to evaluate the efficacy and safety of ABT13107 compared to Hyalobarrier applied to postoperative intrauterine.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 192
Inclusion Criteria
- Female patients aged from 19 to 70
- Those who are scheduled for hysteroscopy to treat the following diseases: submucosal myomas, endometrial polyps, intrauterine adhesion etc.
Exclusion Criteria
- Those who will apply other intrauterine device rather than investigational device during the study period.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Incidence of intrauterine adhesion 4 weeks Incidence rate of intrauterine adhesion after surgery
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Asan Medical Center
🇰🇷Seoul, Korea, Republic of
Asan Medical Center🇰🇷Seoul, Korea, Republic of