A Prospective Study on Radiofrequency Ablation of Uterine Fibroids (Myolysis) Under Ultrasound and Endoscopic Guidance, in Single or Combined Approach
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 54
- 试验地点
- 2
- 主要终点
- Myoma volumes after radiofrequency myolysis (RFM)
研究概览
简要总结
To perform the use of radiofrequency myolysis (RFM) for the treatment of intra-uterine fibroids through less invasive access by combining trans-vaginal ultrasound, hysteroscopy and laparoscopy
详细描述
Given that the RF ablation of solid tumors of the liver and other organs is successfully used as a usual approach, the investigators have decided to transfer this technology to an original treatment of uterine fibroids. The access to each individual fibroid was determined considering passage of the needle towards its centre through only compromised tissue and by the shortest possible route by combining trans-vaginal ultrasound, hysteroscopy and laparoscopy. To optimize radiofrequency myolysis, in fact, the investigators decided to improve the procedure by inserting three innovative elements: application of a virtual needle tracking system to follow the RF electrode during the ablation session, real-time monitoring of RF ablation by contrast-enhanced ultrasound and systematic biopsy of the lesions before electro-coagulation.
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
- 30 Years 至 62 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •"Inclusion Criteria":
- •women who had symptomatic myomas with diameters ranging between 1.2 and 7.7 cm. - patients who had declined hysterectomy or laparoscopic myomectomy
- •submucosal fibroids with intramural extension ≥50%
- •intramural fibroids (FIGO G3 / G4 types)
- •subserosal fibroids (FIGO G5 / G6 types)
排除标准
- •Women with intracavitary (FIGO G0 / G1 types) or subserosal-pedunculated fibroids / (FIGO G7 types)
- •genital malignancy
- •cervical dysplasias
- •pelvic infection / adhesions
- •severe systemic diseases
- •pregnancy
- •deeply infiltrating endometriosis
- •patients who took gonadotropin-releasing hormone therapy or acetate ulipristal within 6 months
研究组 & 干预措施
Radiofrequency myolysis of uterine fibroids
54 premenopausal participants with symptomatic uterine myomas
干预措施: RADIOFREQUENCY ABLATION OF UTERINE MYOMAS (Device)
结局指标
主要结局
Myoma volumes after radiofrequency myolysis (RFM)
时间窗: 12 months
The outcomes evaluated after RFM were myoma volumes (cubic centimeters)
Uterine Fibroid Symptom and Quality of Life (UFS-QOL) score after radiofrequency myolysis (RFM)
时间窗: 12 months
Uterine Fibroid Symptom and Quality of Life (UFS-QOL) questionnaire with scores ranging from 0 to 100, were higher QOL scores mean a better health-related QOL 1 and a 10-point scale used for each reported symptom.
Myoma diameters after radiofrequency myolysis (RFM)
时间窗: 12 months
The outcomes evaluated after RFM were myoma diameters (centimeters)
次要结局
- Surgical time of radiofrequency myolysis (RFM) assisted by new technologies(12 months)
- Surgical time of radiofrequency myolysis (RFM)(12 months)
- Pre-intervention biopsy associated to radiofrequency myolysis (RFM)(12 months)
研究者
Alessandro FASCIANI
MD - Principal Investigator
International Evangelical Hospital