Evaluation of the Gynesonics System for Transcervical Treatment of Symptomatic Uterine Fibroids With Radiofrequency Ablation Under Integrated Intrauterine Sonography Guidance
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 147
- 试验地点
- 45
- 主要终点
- Percentage of Subjects With ≥ 50% Reduction in Menstrual Blood Loss as Assessed by Pictorial Blood Loss Assessment Chart (PBAC)
研究概览
简要总结
The objective of this study is to establish the safety and effectiveness of the Sonata® System in the treatment of symptomatic uterine fibroids.
详细描述
In this single-arm study, subjects who have symptomatic uterine fibroids will have transcervical RF ablation of uterine fibroids under intrauterine ultrasound guidance using the Gynesonics Sonata System.
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
- 25 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •premenopausal
- •≥ 25 and ≤ 50 years of age at time of enrollment
- •experienced heavy menstrual bleeding associated with fibroids (AUB-L) for at least 3 months
- •between 1-10 fibroids of FIGO types 1, 2, 3, 4, and/or type 2-5, with diameter ≥ 1.0 cm and ≤ 5.0 cm
- •at least one type 1, type 2, type 3, or type 2-5 fibroid.
- •PBAC score ≥ 150 and ≤ 500
- •consistent menstrual cycles
- •not at material risk for pregnancy
- •speaks and reads a language for which validated questionnaires are available
- •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
- •pregnancy
- •urgent need for surgery to treat fibroid symptoms
- •desire for current or future childbearing
- •presence of a tubal implant for sterilization
- •postmenopausal by history
- •presence of type 0 fibroids, unless < 1 cm in diameter
- •presence of a single polyp ≥ 1.5 cm, or multiple polyps of any size
- •any fibroid of FIGO type 1, type 2, type 3, type 4, or type 2-5 with diameter > 5.0 cm
- •bulk symptoms in the presence of one or more fibroids of FIGO type 5, type 6, or type 7
- •exclusive presence of fibroids that are insufficient to explain the severity of symptoms
- •presence of clinically relevant fibroids that cannot be treated for technical reasons
- •presence of an extrauterine pelvic mass that has not been diagnosed as benign
- •IUD/IUS in situ within the washout period
- •previous procedure for fibroids or heavy menstrual bleeding other than myomectomy
- •myomectomy within 12 months
- •any abnormality of the endometrial cavity that obstructs access of the handpiece
- •contraindication to MRI
- •total uterine volume > 1000 cc
- •clinically significant adenomyosis
- •confirmed or suspected diagnosis of clinically relevant endometriosis
- •one or more clinically relevant fibroids that are significantly calcified.
- •previous pelvic irradiation
- •renal insufficiency [serum creatinine ≥ 1.5 mg/dL (132.6 μmol/L)]
- •evidence of disorders of hemostasis (AUB-C)
- •abnormal cervical cytology that is unevaluated or untreated in adherence with national guidelines
- •endometrial hyperplasia (AUB-M), including simple hyperplasia without atypia
- •confirmed abdominal / pelvic malignancy within the previous five years
- •active pelvic infection or current positive testing for pelvic gonorrhea or chlamydia;
- •use of a hormonally-relevant medication within the washout period
- •use of an antifibrinolytic agent while undergoing any screening procedures
- •current use of anticoagulant therapy
- •chronic pelvic pain (disruptive for at least six months) or significant baseline pelvic or menstrual pain
- •chronic uncontrolled moderate and severe hypertension
- •hypoplastic or otherwise short uterus
- •major medical or psychiatric illness or other factors that may affect general health or subject's ability to adhere to the follow-up schedule or provide valid subject self-assessment data
- •any other reason for which the individual study subject is not appropriate or suitable for participation
结局指标
主要结局
Percentage of Subjects With ≥ 50% Reduction in Menstrual Blood Loss as Assessed by Pictorial Blood Loss Assessment Chart (PBAC)
时间窗: Baseline and 12 Months
The proportion of subjects with a minimum of 50% reduction in menstrual blood loss at 12 months post-procedure compared to baseline as assessed by PBAC. Success for individual subjects was defined as a ≥ 50% reduction from baseline in menstrual blood loss and a final PBAC score \< 250. Endpoint success was defined as the lower confidence limit of the percentage of subject success ≥ 45%. The PBAC is a validated tool used to diagnose heavy menstrual bleeding and track menstrual bleeding. Women were asked to record daily use of tampons and sanitary towels by placing a tally mark under the day next to the box that represented how stained the sanitary materials were each time they were changed during the menstrual cycle. The tally marks were added up depending on the saturation level to provide a score. The score does not have an upper limit as it is not a "scale". PBAC ≥ 150 is associated with heavy menstrual bleeding.
Percentage of Subjects Without Surgical Re-intervention for Heavy Menstrual Bleeding Due to Treatment Failure
时间窗: 12 Months
This endpoint computed the rate of not having a surgical reintervention for heavy menstrual bleeding due to treatment failure. As the success criterion for this endpoint was "no surgical reintervention for HMB due to treatment failure at 12 months", the endpoint assessed the rate of subjects without surgical reintervention success due to treatment failure within the 12-month post-treatment period. Rate was calculated using the life-table method.
次要结局
- Percentage Change in Total and Perfused Mean Maximal Fibroid Volumes at 12 Months(Baseline and 12 Months)
- Pregnancy Outcome - Birth Weight(24 Months)
- Subject Pain(Immediately Post-procedure as well as Pre-discharge (Day 0))
- Procedure Tolerance(Post-procedure (Day 0))
- Safety - Percentage of Subjects With Adverse Device Effects (Serious or Non-serious)(Each Follow-up Visit through 24 Months)
- Change in General Health State at 12 Months(Baseline and 12 Months)
- Occurrence of Pregnancy(All Follow-up Visits through 24 Months)
- Change in Work Productivity and Activity Impairment Due to Uterine Fibroid Symptoms at 12 Months(Baseline and 12 Months)
- Time to Return to Normal Activity (RTNA) in Days(30 Day post-procedure)
- Subject Satisfaction With Treatment at 12 Months(12 Months)
- Subject Willingness to Recommend Procedure at 12 Months(12 Months)
- Change in the Symptom Severity Score (SSS) and Quality of Life (HR-QoL) Subscales of the Uterine Fibroid Symptom and Quality of Life (UFS-QoL) Questionnaire at 12 Months(Baseline and 12 Months)
- Overall Treatment Effect (OTE) at 12 Months(12 Months)
- Mean Length of Stay(Day 0 - Day of Treatment)
- Pregnancy Outcome - Gestation Age(24 Months)