NL-OMON43153已完成不适用
Evaluation of the Gynesonics System for Transcervical Treatment of Symptomatic Uterine Fibroids with Radiofrequency Ablation under Integrated Intrauterine Sonography Guidance - Sonography-Guided Transcervical Ablation of Uterine Fibroids (SONATA)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1) Are premenopausal
- •2) Are * 25 and * 50 years of age at time of enrollment
- •3) Have experienced heavy menstrual bleeding associated with fibroids (AUB-L) for at least the previous three months as reported by the subject
- •4) Have * 1 and * 10 fibroids of FIGO types 1, 2, 3, 4, and/or type 2-5, with diameter * 1.0 cm and * 5.0 cm as determined by credentialed transvaginal sonography or magnetic resonance imaging (MRI). Fibroids of type 5, 6, and 7 do not count toward the clinically relevant total, irrespective of size.
- •5) Have at least one type 1, type 2, type 3, or type 2-5 fibroid.
- •6) Pictorial blood loss assessment chart (PBAC) score * 150 and * 500 during a single baseline cycle
- •7) Consistent menstrual cycles of between 22 to 35 days in duration that meet the following requirements for at least 4 of the last 6 menstrual cycles prior to enrollment as reported by the subject: (1) Variations in cycle length of no more than +/- 4 days, and (2) Bleeding duration of 3-10 days, in which the bleeding requires use of more than a pantiliner
- •8) Subject is not at material risk for pregnancy (not sexually active; has been sterilized; does not have a male partner or is in a monogamous relationship with a sterilized male partner; reliably uses barrier contraception, or oral or vaginal hormonal contraception. Subject is willing to maintain use or non-use of non-injectable hormonal contraception uniformly from 6 months pre-study through the 12-month follow-up period.1. If a subject is on oral/vaginal hormonal contraception solely for bleeding control, or if a subject does not wish to commit to 12 months of consistent hormonal contraceptive use, subject must discontinue use as per the washout period specified in Appendix H (protocol).
- •9) Speaks and reads a language for which validated questionnaires are available
- •10) Willing and able to read, understand, and sign the informed consent form, to participate in the study and to adhere to all study follow-up requirements
排除标准
- •1) Pregnancy, as determined by urine or serum hCG obtained within 24 hours prior to treatment with Sonata
- •2) Urgent need for surgery to treat fibroid symptoms
- •3) Desire for current or future childbearing
- •4) Presence of a tubal implant for sterilization
- •5) Postmenopausal by history
- •6) Presence of type 0 fibroids, unless < 1 cm in diameter and are unlikely to contribute to bleeding in the judgment of the investigator.
- •7) Presence of a single polyp 1.5 cm, or multiple polyps of any size, within the uterine cavity, or excision of polyps within three months of completing any screening procedures
- •8) Any fibroid of FIGO type 1, type 2, type 3, type 4, or type 2-5 with diameter > 5.0 cm as determined by transvaginal sonography or magnetic resonance imaging (MRI)
- •9) Bulk symptoms (pelvic pressure, frequent urination) that significantly interfere with normal daily activities in the presence of one or more fibroids of FIGO type 5, type 6, or type 7
- •10) Exclusive presence of fibroids that, despite meeting other eligibility criteria, are insufficient to explain the severity of symptoms in the judgment of the Investigator
- •11) Presence of clinically relevant fibroids that cannot be treated for technical reasons (e.g. cervical fibroid)
- •12) Presence of an extrauterine pelvic mass that has not been diagnosed as benign
- •13) IUD/IUS in situ within the washout period specified in Appendix H (protocol) prior to undergoing any screening procedures
- •14) Not used
- •15) Previous procedure for fibroids or heavy menstrual bleeding other than myomectomy. Examples of excluded procedures: endometrial ablation, uterine artery/fibroid embolization, uterine artery occlusion, MR guided focused ultrasound, radiofrequency ablation.
- •16) Myomectomy by any route within 12 months prior to undergoing any screening procedures, or myomectomy > 12 months with less than 6 months of symptom relief
- •17) Any abnormality of the endometrial cavity that, in the judgment of the Investigator, obstructs access of the Sonata Handpiece to the endometrial cavity or fibroids (e.g., significant intrauterine synechiae)
- •18) Contraindication to MRI, including MR-incompatible implants, allergy to contrast media or claustrophobia, and weight that is above the limitation of the site-specific MRI scanner credentialed for the study
- •19) Total uterine volume * 1000 cc as determined by transvaginal sonography
- •20) Clinically significant adenomyosis based on sonography; presence confirmed by MRI (defined as more than 10% of the junctional zone measuring more than 10 mm in thickness as measured by MRI)
- •21) Confirmed or suspected diagnosis of clinically relevant endometriosis
- •22) One or more clinically relevant fibroids that are significantly calcified. If suspicion of calcification, refer to MRI. (Significant calcification is defined as being associated with a majority of the fibroid not showing enhancement on volume via contrast-enhanced MRI)
- •23) Previous pelvic irradiation
- •24) Not used
- •25) Renal insufficiency [serum creatinine * 1.5 mg/dL (132.6 *mol/L)]
- •26) Evidence of disorders of hemostasis (AUB-C) as assessed through structured interview and confirmed by hematologic evaluation consistent with a coagulopathy (see Appendix D)
- •27) Abnormal cervical cytology that is unevaluated or untreated in adherence with national guidelines
- •28) Endometrial hyperplasia (AUB-M), including simple hyperplasia without at
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