Uterine Leiomyoma Treatment With Radiofrequency Ablation (ULTRA) Registry
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 578
- 试验地点
- 14
- 主要终点
- Changes in fibroid-related symptoms after the RFA or myomectomy procedure.
研究概览
简要总结
The ULTRA Registry is a nationwide observational arm of the ULTRA trial. Data from the ULTRA Registry will be used to evaluate the long-term safety and efficacy of laparoscopic RF ablation (Acessa).
The ULTRA Registry will recruit women age 21 or older who plan to undergo or have undergone laparoscopic RF ablation (Acessa) or myomectomy within the United States. Participants will be recruited through study materials distributed at clinical offices across the country where gynecologists are performing laparoscopic RF ablation (Acessa). Study participants will consent to participate in a 3 year prospective study conducted by UCSF but the fibroid procedure will be performed by the study participants' own gynecologist. We will evaluate changes in fibroid-related symptoms from pre-treatment values to 6, 12, 18, 24, 30, and 36 months after RFA (Acessa). We will determine long-term efficacy of RFA (Acessa) by evaluating the rate of re-treatment for symptomatic fibroids after the RFA (Acessa) procedure versus myomectomy. Participants will be asked for permission to review their medical records to assess surgical and pregnancy outcomes.
UC San Francisco will have oversight of all scientific and administrative aspects of the study. All study data will be stored securely in a HIPAA compliant, secure database monitored by the UC San Francisco Coordinating Center.
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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Planning to undergo or have undergone* RF ablation (Acessa) or myomectomy (laparoscopic or abdominal) for treatment of uterine fibroids.
- •Able to give informed consent
- •Speak English or Spanish
- •Women enrolled at contracted clinical sites must enroll prior to their RF ablation treatment
排除标准
- •<21 years of age
- •Plan to undergo hysteroscopic myomectomy
研究组 & 干预措施
Women undergoing radiofrequency ablation.
Most women (75%) in the trial will be in the group who receive treatment with radiofrequency ablation (Acessa).
干预措施: Radiofrequency ablation of fibroids (Procedure)
Women undergoing myomectomy
About 25% of women in the trial will be in the group who receive treatment with myomectomy.
干预措施: Myomectomy of fibroids (Procedure)
结局指标
主要结局
Changes in fibroid-related symptoms after the RFA or myomectomy procedure.
时间窗: Baseline to 3 years
We will use standard questionnaires for women with fibroids to assess changes in fibroid symptoms including menstrual pattern and flow and overall quality of life.
次要结局
- Rate of re-intervention for recurrent fibroid symptoms following the RFA or myomectomy procedure.(Baseline to 6 weeks)
- Operative complications(Baseline to 6 weeks)
- Pregnancy rate after the RFA or myomectomy procedure.(Baseline to 3 years)