Long Term Effectiveness of Uterine Sparing Fibroid Treatments
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 700
- 试验地点
- 4
- 主要终点
- Time to treatment failure
研究概览
简要总结
The goal of the ALOFT study is to understand the health of women in the 12 years following a uterine fibroid (UF) treatment. ALOFT is a multi-center, prospective, observational cohort study of approximately 700 women who have undergone uterine-sparing treatment procedures for UF and previously participated in the longitudinal studies COMPARE-UF (NCT02260752) or ULTRA (NCT02100904).
The primary uterine sparing treatment procedures undergone by study participants are myomectomy, endometrial ablation (EA), uterine artery embolization (UAE) and laparoscopic radiofrequency ablation (RFA). A smaller number of women may be studied who underwent focused ultrasound, intrauterine device (IUD), and medical management.
Two follow-up study contacts with COMPARE-UF and ULTRA participants will occur to assess changes in UF symptoms and treatment failure which is defined as the need for another UF treatment procedure. Questionnaires will be used to collect data on patient-reported characteristics and outcomes and quality of life.
The study's analyses will focus on comparisons of primary and secondary outcomes among women.
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
- •Participant has to have been enrolled in either the COMPARE-UF or ULTRA study
- •Participant had a uterine-sparing fibroid treatment at enrollment in COMPARE-UF or ULTRA study
排除标准
- •Individuals who were not consented into the original COMPARE-UF or ULTRA study
- •Individuals who did not have a uterine-sparing fibroid treatment at enrollment in COMPARE-UF or ULTRA study
结局指标
主要结局
Time to treatment failure
时间窗: Up to 12 years
The need for another uterine fibroid treatment procedure
次要结局
未报告次要终点
研究者
Ganesa Wegienka
Principal Investigator
Henry Ford Health System