Evaluation of Uterine Patency Following Sonography-guided Transcervical Ablation of Fibroids
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 37
- 试验地点
- 6
- 主要终点
- Number of Participants With Absence of Newly Formed Intrauterine Adhesions Following RF Ablation of Fibroids
研究概览
简要总结
This study is designed to observe the presence or absence of intrauterine adhesions at 6 weeks after treatment with the Sonata® System through hysteroscopic evaluation by third party readers.
详细描述
Patients who agree to participate in this observational trial will have selected fibroid treatment with the Sonata System. Research participants will undergo hysteroscopy at 6 weeks following treatment to evaluate presence or absence of intrauterine adhesions.
Research participants will be asked to complete a quality of life questionnaire prior to and 6 weeks following treatment. Research participants will also complete a satisfaction survey and a diary that tracks their return to normal daily activities.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Have selected Sonata for treatment of fibroids in the presence of heavy menstrual bleeding
- •Presence of at least one submucous myoma (type 1, type 2) or transmural fibroid (type 2-5)
- •Willing and able to read, understand, and sign the informed consent form and to adhere to all study follow-up requirements
排除标准
- •Preexisting adhesions within the endometrial cavity as indicated by an ESH score ≥ I as determined by the investigator
- •One or more Type 0 fibroids and/or endometrial polyps of any size
- •Any reason for which, in the opinion of the Investigator, the individual study patient is not appropriate or suitable for participation in this study
结局指标
主要结局
Number of Participants With Absence of Newly Formed Intrauterine Adhesions Following RF Ablation of Fibroids
时间窗: 6 weeks
Hysteroscopic evaluation by independent readers to determine the presence or absence of adhesions following transcervical RF ablation of fibroids with the Sonata system in participants who completed the follow-up assessment AND evaluable hysteroscopy videos.
次要结局
- Umber of Participants With Absence of Newly Formed Adhesions Following RF Ablation of Fibroids in Participants With Apposing Fibroids Treated(6 weeks)