A Prospective, Observational, Multi-center Study to Gather Real World Use Data on the Effectiveness, Safety, and Site-of-service of the Cerene Device
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 300
- 试验地点
- 4
- 主要终点
- Patient quality of life
研究概览
简要总结
Channel Medsystems, Inc., the manufacturer of the Cerene® Cryotherapy Device (Cerene), is initiating a prospective, observational registry, the Progress registry, to gather data during real world utilization of the Cerene® Cryotherapy Device (Cerene). The primary objective of this registry is to bridge the gap between clinical results and outcomes achieved and reported during the pivotal study of Cerene and those obtained during its real-world use.
详细描述
Cerene was approved by the FDA in March 2019 for endometrial cryoablation in premenopausal women with heavy menstrual bleeding due to benign causes for whom child bearing is complete. The primary objective of the Progress registry is to bridge the gap between clinical results and outcomes reported during the pivotal study of Cerene (the CLARITY Study) and those observed during its real-world use. The Progress registry will gather prospective, observational data on up to 300 women that underwent a Cerene treatment. Patients and physicians will complete surveys. Surveys will include patient demographic characteristics and quality of life measures at baseline, procedural details, and post-operative clinical outcomes and quality of life measures.
Patient participation is expected to last approximately 13 months, from the time of patient enrollment to 12 months post treatment. The study will end after the last participating patient in completes her 12 month visit.
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
- 25 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Scheduled for a Cerene treatment
- •25 years of age and older
- •Provided informed consent to participate in the registry
- •English speaking
- •Agrees to complete a survey at specified time points from baseline to 12 Months
排除标准
- •Physician discretion
- •Vulnerable populations
研究组 & 干预措施
Treated patients
This is a registry study with no active intervention outside standard of care. Women will be treated with Cerene per standard of care.
干预措施: Cerene (Device)
结局指标
主要结局
Patient quality of life
时间窗: 12 Months
The patient's quality of life at baseline and 12 Months will be compared.
Re-intervention rate
时间窗: 12 Months
The cumulative re-intervention rate at 12 months will be compared to the pivotal clinical study.
Site of service rate
时间窗: 12 Months
The mix of Cerene treatments performed at different sites of service will be tabulated.
次要结局
- Cost analysis(12 Months)
- Physician survey(12 Months)