To Evaluate Anti-adhesive Effect and Safety of a Mixed Solid of Poloxamer, Gelatin and Chitosan(Mediclore®)
Not Applicable
- Conditions
- Gynecologic Disease
- Interventions
- Device: Mediclore® (adhesion barrier)
- Registration Number
- NCT02957500
- Lead Sponsor
- CGBio Inc.
- Brief Summary
The purpose of this study is to evaluate the efficacy and safety of Mediclore®, as an antiadhesive barrier, which is made of Poloxamer, Gelatin and Chitosan.
- Detailed Description
to evaluate the efficacy and safety of Mediclore®, as an antiadhesive barrier
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 198
Inclusion Criteria
- the patients with submucosal myomas, endometrial polyps, intra-uterine adhesion, uterine septa, dysfunctional uterine bleeding
- Written informed consent
- Patients without clinically significant lab
Exclusion Criteria
- having enrolled another clinical trials within 1 month
- Immunosuppression or autoimmune disease
- Anticoagulant, general steroids within a week from surgery
- Incompatible medications
- Serious diseases (heart failure, renal failure, liver failure, uncontrolled hypertension, diabetes mellitus, coagulation deficiencies)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Mediclore® Mediclore® (adhesion barrier) adhesion barrier Mediclore 5cc, to apply medical device fully around intrauterine surgery area
- Primary Outcome Measures
Name Time Method Adhesion incidence rate following 4 weeks 4weeks
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
CHA kangnam medical center, CHA university
🇰🇷Seoul City, Korea, Republic of