Safety and Efficacy of Intrauterine Biological Barrier on Postoperative Adhesion After Hysteroscopic Adhesiolysis: a Prospective, Multicentre, Randomized, Positive Parallel Controlled, Non-inferiority, Clinical Trail
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 264
- 试验地点
- 6
- 主要终点
- Effective rate
研究概览
简要总结
To evaluate the safety and efficacy of Intrauterine Biological Barrier developed and produced by Chengdu TopRegMed Medical Technology Co., Ltd on postoperative adhesion after Hysteroscopic Adhesiolysis.
详细描述
This study is a prospective, multicenter, randomized, parallel positive-control, non-inferior clinical trial, with the purpose to evaluate the efficacy and safety of Intrauterine Biological Barrier for the prevention or reduction of intrauterine adhesions after Hysteroscopic Adhesiolysis.
The trial will be conducted at six clinical centers with 264 subjects who meet all the inclusion/ exclusion criteria. Subjects will be randomly assigned to the experimental group and the control group in a 1:1 ratio. Subjects in the test group were treated with Intrauterine Biological Barrier (IBB) made by Chengdu TopRegMed Medical Technology Co. , Ltd. , while the patients in the positive control group were treated with commercially approved Intrauterine Adhesion Barrier Gel for uterine cavity made by Changzhou Bioregen biopharmaceutical Co. , Ltd. .
Subjects will be followed up for 12 months (360 days ± 30 days) after implantation. 73-days (± 12 days) after operation, the safety and effectiveness of IBB will be evaluated by demonstrating non-inferiority to commercially approved gel. If test group is non-inferiority, further study will be performed to explore whether the safety and effectiveness of the IBB is better than the control group in the aspect of the recurrence rate of intrauterine adhesion, types of intrauterine adhesion, postoperative endometrial repair, menstrual recovery and 1-year pregnancy rate.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •（1）Age, yr20-40 (including boundary value), Female
- •（2）Normal ovarian reserve function (FSH<10U/ml，AMH>2ng/ml)
- •（3）Who suffered from moderate to severe intrauterine adhesions (AFS ≥ 5 points) diagnosed by hysteroscopy, and prepared to be treated by Hysteroscopic adhesiolysis
- •（4）Both husband and wife have fertility intention during treatment
- •（5）Accept to treatment and follow-up visits, Sign the ICF
排除标准
- •（1）Severe systemic diseases, contraindications of surgical and cycle
- •（2）Inflammation of reproductive tract, genital tuberculosis, pelvic infection, tumor of reproductive organs
- •（3）Systemic diseases cause uterine bleeding
- •（4）Allergic to hyaluronic acid or components
- •（5）Allergic to swine sources medical device, or refuse to swine sources medical device for religious, ethnic and other reasons
- •（6）Insufficient uterine cavity volume after Hysteroscopic adhesiolysis to place Intrauterine Biological Barrier or inject Intrauterine Adhesion Barrier Gel
- •（7）Involved other clinical trial before Hysteroscopic adhesiolysis in 3 months or during the trail
- •（8）Unable to tolerate anesthesia
- •（9）Estrogen medicine was taken within 30 days of Hysteroscopic adhesiolysis
- •（10）Other inadequacy patient assessed by the researchers
结局指标
主要结局
Effective rate
时间窗: Day 73±12
At second-look hysteroscopy after Hysteroscopic adhesiolysis, the effective rate (%) = (number of cured + number of apparent effect)/total number in the group × 100%
次要结局
- Duration of Menstrual recovery(Day 73±12, Day 100±10 , Day 180±30, Day 360±30)
- Endometrial improvement(Day -7 to day 1, Day 100±10)
- Menstrual blood volume(Day 73±12, Day 100±10 , Day 180±30, Day 360±30)
- Recurrence rate of adhesions(Day 73±12)
- Pregnancy rate after operation 1year(Day 360±30)
- Time of menstrual recovery(Day 73±12)
- Extent of uterine adhesions(Day 73±12)
研究者
Limin Feng
Director of Obstetrics and Gynecology
Beijing Tiantan Hospital