KCT0002946
Completed
未知
The Prospective, multicenter, double-blinded(Subject-independent evaluator), randomized, and pivotal clinical trial to compare the efficacy and safety of Collabarrier® with Guardix-SOL for the prevention of postoperative adhesion in Intrauterine surgery.
Dalim Tissen0 sites188 target enrollmentTBD
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Dalim Tissen
- Enrollment
- 188
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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