Uterine Leiomyoma Treatment With Radiofrequency Ablation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 5
- 主要终点
- Changes in fibroid-related symptoms after the Acessa procedure.
研究概览
简要总结
The ULTRA study is a single-arm trial of 100 premenopausal women with symptomatic uterine fibroids who undergo treatment with the Acessa device. The Acessa device is a new FDA approved minimally invasive treatment for uterine fibroids that uses radiofrequency energy to destroy fibroid tissue. The fibroids then shrink and symptoms are significantly improved. The radiofrequency energy is delivered to the fibroids during an outpatient surgical procedure. There is minimal blood loss and pain and women return to the usual activities 5-9 days after the Acessa procedure.
The investigators will evaluate changes in fibroid-related symptoms from before the Acessa treatment to 3, 6, 12, 18, 24, 30, and 36 months after Acessa treatment. The investigators will also assess operative outcomes including procedure duration, complications, blood loss, post-operative pain, and the time to return to usual activities. The investigators will determine long-term efficacy of Acessa by evaluating the rate of re-treatment for symptomatic fibroids after the Acessa procedure.
Study participants will be recruited at 5 sites within the UC Fibroid Network: UC Davis, UC Irvine, UC Los Angeles, UC San Diego, and UC San Francisco. UC San Francisco will serve as the Coordinating Center for the trial with 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. A data safety and monitoring board will oversee participant safety and protection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Premenopausal (at least 1 menstrual period in last 3 months)
- •Age >21years
- •Fibroids are associated with heavy bleeding, pelvic pressure or discomfort, urinary or bowel symptoms, or dyspareunia
- •Desires surgical management of fibroids
- •Uterus ≤16 weeks in size
- •All fibroids ≤ 10cm in maximum diameter by ultrasound or MRI assessment within the last year.
- •Total number of fibroids ≤6 by ultrasound or MRI assessment within the last year. (For this study "Fibroids" will be leiomyomas > 2cm)
- •Had a Pap smear within the last 3 years with appropriate follow-up and treatment for cellular abnormalities
- •Endometrial biopsy indicates no hyperplasia or cancer (biopsy only required if age >45 years and has anovulatory heavy bleeding)
- •Able to tolerate laparoscopic surgery
- •Able to give informed consent
排除标准
- •Planned treatment for infertility
- •Pedunculated fibroid with thin stalk (total stalk length is <25% maximum diameter of fibroid)
- •Intracavitary (FIGO Type 0) fibroid
- •Symptomatic fibroids are only FIGO Type 1 (submucosal with ≥ 50% intracavitary)
- •Planned concomitant surgical procedure in addition to treatment of uterine fibroids
- •Use of Essure or any other metallic, implantable device within pelvis
- •Pelvic infection with the last 3 months
- •History of pelvic malignancy and/or pelvic radiation
- •Known or high suspicion for dense pelvic adhesions
- •Fibroids treated by myomectomy, uterine artery embolism, radio-frequency ablation, MRI Guided focused ultrasound, or cryomyolysis within the last 3 months
研究组 & 干预措施
Acessa
All women in the trial will be in this group who receive treatment using the Acessa device.
干预措施: Radiofrequency ablation of fibroids (Procedure)
结局指标
主要结局
Changes in fibroid-related symptoms after the Acessa procedure.
时间窗: Baseline to 3 years.
Changes as assessed by standard questionnaires for fibroid symptoms including menstrual pattern and flow and overall quality of life.
次要结局
- Re-intervention for recurrent fibroid symptoms following the Acessa procedure.(Baseline to 3 years)
- Operative complications(Baseline to 6 weeks)
- Pregnancy after the Acessa procedure(Baseline to 3 years)