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临床试验/NCT02631278
NCT02631278Unknown不适用

Tissue Effect in Extirpated Uterine Fibroid Tissue Using Existing Olympus Radiofrequency Probes for Fibroids Ablation (Radio Frequency Ablation RFA STUDY )

Catholic University of the Sacred Heart4 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2014年12月最近更新:
适应症

试验速览

阶段
不适用
入组人数
10
试验地点
4
主要终点
Estimation termal dose

研究概览

简要总结

The aim of this study is to investigate the safety and feasibility of a radiofrequency (RF) system employing RFITT (CelonProSurge) probes for the ablative treatment of uterine fibroids.

详细描述

10 consecutive premenopausal women with symptomatic uterine fibroids not responsive to medical therapies (including progestins, oral contraceptives, and anti-inflammatory drugs) will be recruited at our hospital to be submitted to abdominal myomectomy. All patients will be counseled on the potential risks and benefits of the procedure before giving their own written consent.

Procedures will be performed at the hospital and patients will be under general anesthesia.All patients will be submitted to abdominal myomectomy. Target leiomyomas will be intramural, 5-15 cm in diameter. Intra-operative RF ablation will be carried out followed by surgical removal of the treated leiomyoma. After the removing of the fibroid, it will be send to the pathologist. Specimens of fibroid will be fixed immediately in 10% neutral formaline solution for approximately 3h, then embedded in paraffin, cut into 4mm section and stained with along the direction of the RFA electrode. Pathologic confirmation of ablation will be assessed as follows: the specimens of leiomyoma will be examined grossly for the histologic leiomyoma subtype and for pathologic findings representing treatment, including necrosis, hemorrhage, or fibrosis, using hematoxylin and eosin staining. Treated areas will be measured for their largest orthogonal dimensions in the planar cut surface with the third dimension estimated by summing the affected 0.5-cm-thick sagittal planes. RF ablation volumes will be calculated using the prolate ellipsoid formula. The relationship between thermal dose estimates and pathology will be assessed using Bland-Altman analyses and intra-class correlations. The surgical procedure will be concluded as usual with the same steps of standard approach.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
盲法
None

入排标准

年龄范围
25 Years 至 70 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • premenopausal women, 25 years of age or older;
  • presence of fibroid-related symptoms (menorrhagia, pelvic pain and/or bulk symptoms) not responsive to medical therapy;
  • uteri <20-week gestational size on pelvic examination;
  • one myoma 5-15 cm in diameter as measured by transvaginal ultrasound;
  • desire for uterine preservation;
  • normal coagulation profile;
  • normal Pap test result in the last year,
  • hemoglobin level of 10.0 g/dL or more at the time of treatment.

排除标准

  • pedunculated subserosal or intracavitary myomas,
  • a history of pelvic malignancy,
  • presence of cervical dysplasia,
  • a prior procedure to treat or remove myomas,
  • contraindications to general anesthesia or abdominal surgery.

结局指标

主要结局

Estimation termal dose

时间窗: Intraoperative time

Specimens of fibroid will be fixed immediately in 10% neutral formaline solution for approximately 3h, then they will be embedded in paraffin, cut into 4mm section and stained with along the direction of the RFA electrode. Pathologic confirmation of ablation will be assessed as follows: the specimens of leiomyoma will be examined grossly for the histologic leiomyoma subtype and for pathologic findings representing treatment, including necrosis, hemorrhage, or fibrosis, using hematoxylin and eosin staining. Treated areas will be measured for their largest orthogonal dimensions in the planar cut surface with the third dimension estimated by summing the affected 0.5-cm-thick sagittal planes. RF ablation volumes will be calculated using the prolate ellipsoid formula. The relationship between thermal dose estimates and pathology will be assessed using Bland-Altman analyses and intra-class correlations.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Prof. Giovanni Scambia

Professor

Catholic University of the Sacred Heart

研究点 (4)

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