Evaluation of Performance and Safety of Hyalosem Cross-linked Hyaluronic Acid Adhesion Barrier Gel in Preventing Intra-uterine Adhesion Formation After Operative Hysteroscopy: A Retrospective Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Incidence and severity of post-operative intrauterine adhesions at second look hysteroscopy
研究概览
简要总结
The aim of this study was to obtain short- and long-term performance and safety data of cross-linked hyaluronic acid-based adhesion barrier gel used to prevent intrauterine adhesion formation.
详细描述
This study was designed as a non-interventional (observational), comparative, retrospective and single-center study. The investigational device has the CE mark under 93/42/ EEC Medical Device Directive and is used in accordance with the intended use declared by the manufacturer in the user manual. Therefore, the study is a post-marketing clinical follow-up (PMCF) study.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Female patients aged 18 and over
- •Patients who were treated with operative hysteroscopy for intrauterine pathology (endometrial polips, myomas with uterine cavity deformation, uterine septa, intrauterine adhesion, ovarian cyst, endometrial cyst, etc.)
- •Patients who had undergone operative hysteroscopy at least 30 days and at most 6 months ago
- •Patients who had second-look office hysteroscopy at least once after an operative hysteroscopy
排除标准
- •Children and adolescents under 18 years of age
- •Having a body weight of more than 100 kg
- •Surgeries complicated by excessive bleeding; estimated blood loss of more than 100 cc
- •Surgeries complicated with uterine perforation
- •Presence of uncontrolled diabetes, coagulation disorders, and other severe chronic disorders
- •Presence of malignant tumor or diagnosis of cancer, presence of uterovaginal prolapse
- •Concomitant peritoneal grafting or tubal implantation
- •Concomitant intrauterine device implantation
- •Patients without second-look hysteroscopy
- •According to the GDPR and clinical investigation legislation, written informed consent is not mandatory in retrospective studies as long as the patient's personal information is censored.
结局指标
主要结局
Incidence and severity of post-operative intrauterine adhesions at second look hysteroscopy
时间窗: 6 months
Incidence and severity (according to AFS classification) of intrauterine adhesions after operative hysteroscopy identified at follow-up diagnostic hysteroscopy
次要结局
- Improvement in menstrual pattern(6 months)
- Adverse events(through study completion)