Transcervical Radiofrequency Ablation of Uterine Fibroids Global Registry (SAGE)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 182
- 试验地点
- 9
- 主要终点
- Incidence of Pregnancy and Pregnancy Outcomes
研究概览
简要总结
SAGE is an observational post market registry with the objective of characterizing long term outcomes after treatment of uterine fibroids with the Sonata System in real world clinical practice settings.
详细描述
Patients whom have selected the CE-marked Sonata system for treatment of fibroids will be approached for study participation. Participation in the trial will consist of data collection in the form of questionnaires prior to and after the treatment at the following intervals: pre-procedure, 4 weeks, 1, 2, 3, 4 and 5 years following treatment.
The following data points will be collected: Length of stay, time to return to normal activities (Treatment Recovery Questionnaire), time to return to sexual activity (Treatment Recovery Questionnaire), change in fibroid symptom severity and quality of life (UFS-QOL), change in general health outcome (EQ-5D), work productivity and activity impairment (WPAI), subject satisfaction and overall treatment effect (Overall Treatment Effect and Satisfaction Questionnaire), pregnancy occurrence and outcome, non-medical re-intervention, adverse events related to the device/procedure.
Validated questionnaires are used where appropriate (UFS-QOL, E1-5D and WPAI). Double data entry will occur to ensure accurate capture of subject reported data. Monitoring will occur throughout the course of the trial to ensure adherence to the protocol.
As an observational trial, there are no pre-specified statistically powered endpoints.
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 symptomatic uterine fibroids or is participating in the OPEN study (Evaluation of Uterine Patency Following Sonography-guided Transcervical Ablation of Fibroids, NCT02844920, protocol # CL04897) or has completed participation in the OPEN study within the last 14 months
- •Speaks and reads a language for which questionnaires are available
- •Are greater than or equal to 18 years of age at the time of enrollment
- •Willing and able to read, understand and sign the informed consent form, to participate in the registry and to adhere to all registry study follow-up requirements
排除标准
- •Any reason for which, in the opinion of the Investigator, the individual study patient is not appropriate or suitable for participation in the registry
结局指标
主要结局
Incidence of Pregnancy and Pregnancy Outcomes
时间窗: Up to 5 years-post procedure
Number of subjects with pregnancy and the number of pregnancies during the 5 year follow-up period. Outcome of each pregnancy including pregnancy outcomes, delivery route, antenatal and perinatal complications.
Surgical Re-intervention for Heavy Menstrual Bleeding
时间窗: Up to 5 years-post procedure
Number of subjects who had surgical re-intervention to treat heavy menstrual bleeding during the 5 year follow-up period.
次要结局
未报告次要终点