A clinical study of the safety and effectiveness of ionized atelocollagen based adhesion barrier(Collabarrier®) for adhesion prevention in hysteroscopic surgery
- Conditions
- Diseases of The genitoruinary system
- Registration Number
- KCT0002946
- Lead Sponsor
- Dalim Tissen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Female
- Target Recruitment
- 188
1. Female at least 19 years old
2. Patients scheduled for intrauterine surgery because of the following gynecological diseases
- Submucosal myoma
- Endometrial polyp
- Uterine septa
- Endometrial hyperplasia
- Intrauterine adhesion
- Abnormal uterine bleeding
3. Patients who are willing to voluntarily participate in the trial and are willing to follow the protocol
If any of the following criteria are met, a target subject can not be enrolled.
? Pregnant, lactating women, and women having a pregnancy plan during the clinical trial
? Patients who intend to use an intrauterine device for contraception during the clinical trial
? Patients who need hormone therapy after intrauterine surgery
? Patients who had GnRH hormone therapy within 3 months before screening
? Patients who have local or systemic infection, endometrial cancer (uterus and endometrium, cervical cancer) and excessive uterine bleeding
? Patients who have abnormal liver function, abnormal kidney function, abnormal hemostatic function
? Patients who are applied anti-coagulants or who took systemic steroids within 1 week before surgical operation
? Patients with immunosuppression or autoimmune diseases
? Patients with uncontrolled diabetes
? Patients with hypersensitivity to the medical device for clinical trials
? Patients who have participated in other clinical trials within 30 days prior to participating in this clinical trial
? In the case that investigators made a decision that a person is inappropriate to participate in the clinical trial
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method the adhesion incidence rate;All adverse events that occurred to the subjects
- Secondary Outcome Measures
Name Time Method the mean score of adhesion type;the mean score of adhesion extent