A randomized, multi-center, evaluator and subject blind, active-controlled, parallel, medical device pivotal clinical study to assess the anti-adhesive effect and safety of ABT13107 compared to Hyalobarrier applied to postoperative intrauterine

Medytox0 个研究点目标入组 192 人开始时间: 待定最近更新: 2020年2月24日

适应症

试验速览

暂无简介。

•1. female between 19 and 69 years of age
•2. Patients diagnosed with submucosal myomas, endometrial polyps, intra-uterine adhesion, uterine septa, dysfunctional uterine bleeding who will undergo hysteroscopy
•3. Given written informed consent

•1. women who planned to use an intra-uterine divice(IUD) or Foley catherter
•2.hormone therapy after hysteroscopic surgery
•3.Stricture and stenosis of cervix uteri, uterine prolapse, pelvic inflammatory disease, cancer, heavy uterine bleeding, cervical infection
•4.local or systemic infection
•5.immunosuppression or auto immune disease
•6.hyperlipidemia
•7. anticoagulants treatment within a week before the operation day
•8. allergies to the study materials
•9. women who were pregnant or who planned pregnancy during the study period
•10. Investigator's opinion that the subject has a concurrent condition that may put the subject at significant risk, may confound the study results, or may interfere significantly with the conduct of the study.
•11.women live with alcohol or drug abuse
•12.women who have been involved in other clinical studies
•13.women who the investigators decided not to enroll in the study

发起方

Medytox