The TRUST (Treatment Results of Uterine Sparing Technologies) U.S.A. Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 114
- 试验地点
- 18
- 主要终点
- Compare direct cost of GFA compared to those of myomectomy and UAE
研究概览
简要总结
This Post Market study is being conducted to compare the direct and indirect cost of three approaches (GFA, myomectomy, and uterine artery embolization) for the treatment of symptomatic uterine fibroids. In addition, data from this study is being used to satisfy the requirements of the United States Food and Drug Administration's 522 (post market surveillance) order.
详细描述
The purpose of this study is to 1) evaluate the economic burden, safety and outcomes of three uterine-conserving treatment alternatives for symptomatic uterine fibroids: myomectomy, uterine artery embolization (UAE), and global fibroid ablation (GFA) using the Acessa™ System, and 2) meet the requirements of the U.S. Food and Drug Administration's 522 Order for post market surveillance In this study, subjects who have symptomatic uterine fibroids will be randomized to one of three uterine-conserving treatments based on the local standard of care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •Are ≥ 18 years old and menstruating
- •Have symptomatic uterine fibroids
- •Have a uterine size ≤ 16 gestational weeks as determined by pelvic exam
- •Have all fibroids that are less than 10 cm in any diameter
- •Desire uterine conservation
- •Have had a normal Pap smear within the past 36 months defined as "no untreated cervical malignancy or dysplasia."
- •Are willing and able to comply with all study tests, procedures, and assessment tools
- •Are capable of providing informed consent.
排除标准
- •Have contraindications for laparoscopic surgery and/or general anesthesia.
- •Are expected to be high risk for, or are known to have, significant intra-abdominal adhesions (defined as adhesions that would require extensive dissection to mobilize and view all surfaces of the uterus)
- •Patients requiring major elective concomitant procedures (e.g., hernia repair)
- •Are pregnant or lactating
- •Have taken any depot gonadotropin releasing hormone (GnRh) agonist within three months prior to the screening procedures
- •Have an implanted intrauterine or fallopian tube device for contraception that cannot or will not be removed at least 10 days prior to treatment
- •Have chronic pelvic pain known to not be due to uterine fibroids
- •Have known or suspected endometriosis Stage 3 or 4, adenomyosis
- •Have active or history of pelvic inflammatory disease
- •Have a history of, or evidence of, gynecologic malignancy or pre-malignancy within the past five years
- •Have had pelvic radiation
- •Have a non-uterine pelvic mass over 3 cm
- •Have a cervical myoma
- •Have one or more completely intracavitary submucous fibroids (Type 0) or only Type 0/1 submucous fibroids that are better treated via hysteroscopic methods
- •In the medical judgment of the investigator should not participate in the study
- •Are not willing to be randomized to treatment.
结局指标
主要结局
Compare direct cost of GFA compared to those of myomectomy and UAE
时间窗: 3 months post procedure
To compare medical, surgical, and hospitalization costs (including procedural complication costs) of Global Fibroid Ablation (GFA) compared to those of Myomectomy and Uterine Artery Embolization (UAE)at 3 months post procedure.
Compare rates of acute and near-term serious complications to the acute and near-term treatment-related serious adverse events of pivotal study.
时间窗: 30 days post procedure
Overall rates of acute (within 48 hours post procedure) and near-term (between 2 and 30 days post procedure) serious complications in all GFA subjects compared to the acute and near-term treatment-related serious adverse event rates in the pivotal study.
次要结局
- Assess the subject's general health outcome(60 months post procedure)
- Assess factors that influence indirect costs of the three treatment alternatives(60 months)
- Assess subjects menstrual bleeding using the MIQ(60 months)
- Assess Uterine Fibroid Symptom Severity and Quality of Life (UFS-QoL) pre-treatment to post treatment in all treatment groups(60 months)
- Assess the incidence and cost of post discharge procedure-related complications and reinterventions(60 months)
- Assess subject's satisfaction with her treatment(12 months)
- Assess the incidence of serious complications per investigator-surgeon during training and post training.(60 months)