A Post-Market Clinical Follow-up Study to Investigate the Usability of the CollaGUARD Adhesion Barrier Following Hysteroscopic Adhesiolysis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 9
- 试验地点
- 2
- 主要终点
- Feasibility of using CollaGUARD in hysteroscopic adhesiolysis: Surgeon completed questionnaire
研究概览
简要总结
Assess the feasibility of CollaGUARD following Hysteroscopic Adhesiolysis.
详细描述
Intrauterine adhesions following gynaecological surgery is a major complication which may cause a range of severe clinical symptoms in women. IUA's can result in menstrual abnormalities, dysmenorrhea and infertility. In pregnancy, adhesions are related to miscarriage, ectopic pregnancy, abnormal placentation, premature labor and delivery and possibly birth defects.
CollaGUARD adhesion barrier is a transparent bioresorbable film approved in Europe for the prevention of postoperative adhesions in patients undergoing abdomino-pelvic laparotomy or laparoscopy.
This study will assess the feasibility of using CollaGUARD adhesion device in hysteroscopic surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with intrauterine adhesions and found eligible for hysteroscopic adhesiolysis
- •Willing to use additional contraception throughout study
排除标准
- •Be pregnant or having a suspected molar pregnancy, lactating, or planning to become pregnant at any time during the study
- •Has suffered or currently suffers from a gynaecological malignancy
- •Has undergone a previous hysteroscopic surgery (such as removal of fibroids)
结局指标
主要结局
Feasibility of using CollaGUARD in hysteroscopic adhesiolysis: Surgeon completed questionnaire
时间窗: following initial hysteroscopy
surgeon completed questionnaire
次要结局
- Change in severity of adhesions(9 weeks post initial hysteroscopy)
- Number of de novo adhesion and adhesion reformation(9 weeks post initial hysteroscopy)
- Degradation of CollaGUARD(2 weeks post initial hysteroscopy)