NCT03028610已完成不适用
Pregnancy Outcome Following Global Fibroid Ablation Using the Acessa™ System
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- Ectopic pregnancy
研究概览
简要总结
Prospective, interventional, single-center, longitudinal, single-arm pilot study to evaluate pregnancies following the Acessa™ treatment of uterine myomas in women who desire future childbearing
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
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Are premenopausal and aged 18 to 40 years.
- •Have already consented to have their fibroids treated with the Acessa™ procedure.
- •Desire pregnancy within two years following Acessa™ treatment
- •Have a normal endometrial cavity as delineated by sonohysterogram within 6 months prior to treatment.
- •Have a uterine size relating to ≤14 weeks of pregnancy, as determined by palpatory pelvic exam.
- •Have fibroids identified by transvaginal ultrasound with:
- •≤6 (six) fibroids of ≤5 cm at the major diameter
- •a total uterine volume of no greater than 300 cc
- •Patients with type 2 fibroids are acceptable for inclusion.
- •Are current in their screening for cervical cancer precursors (i.e. PAP 1 or 2).
- •Are capable of providing informed consent.
- •Are willing and able to comply with all study tests, procedures, and assessment tools during screening and up to 3 years post treatment.
- •Are able to pass a pre-operative health exam (ASA I-III).
- •Patients who are currently undergoing fertility treatments (e.g. Clomid, IVF, etc.) or who are planning such treatments may be enrolled in the study.
排除标准
- •Have contraindications for laparoscopic surgery and/or general anesthesia.
- •Have cervical myomas or Type 0 or Type 1 myomas. Type 0 and Type 1 myomas are excluded as these are generally accessible to hysteroscopic approaches. Cervical myomas are difficult to treat and present a greater risk of bladder or urethral injury.
- •Have one or more Type 0 (completely intracavitary) or Type 1 resectable submucous fibroids.
- •Have known or suspected abdominal adhesions which are expected to complicate laparoscopic surgery.
- •Have known or suspected untreated intra-uterine adhesions or uterine septum.
- •Have previously undergone endometrial ablation, uterine artery embolization, or uterine artery ligation/occlusion, high-intensity focused ultrasound, laparoscopic, hysteroscopic or abdominal myomectomy, or any other uterine-preserving technique for reduction of menstrual bleeding.
- •Subjects taking platelet-inhibiting drugs such as nonsteroidal anti-inflammatory drugs (NSAIDs), aspirin, and clopidogrel
- •Are pregnant or lactating.
- •Have known or suspected severe endometriosis.
- •Have known or suspected adenomyosis.
- •Have active or history of pelvic inflammatory disease.
- •Have a history of or evidence of gynecologic malignancy or pre-malignancy within the past five years.
- •Have had pelvic radiation.
- •Have a persistent and undiagnosed complex adnexal mass.Are unable to give informed consent.
- •In the medical judgment of the investigator should not participate in the study.
研究组 & 干预措施
Acessa™ System
Experimental
radiofrequency generator
干预措施: radiofrequency generator (Device)
结局指标
主要结局
Ectopic pregnancy
时间窗: three years
Vaginal delivery and either
时间窗: three years
i. Uncomplicated delivery or ii. Delivery with complications such as: * Premature rupture of the membranes (PROM) or * Preterm premature rupture of the membranes (PPROM)
Caesarean section delivery and either
时间窗: three years
i. Uncomplicated delivery or ii. Delivery with complications such as: * Preterm delivery * Preterm labor * Uterine rupture * Stillbirths * Postpartum
Spontaneous abortion
时间窗: 6 months
次要结局
- Post-treatment readmission and reintervention rate within 1 month post-procedure assessed by questionnairie(1 month)
- Post-treatment changes in menstrual status up to 36 months post-procedure assessed by a menstrual impact score(three years)
- Post-treatment changes in myoma size as determined by ultrasound(3, 6, 36 months)
- Procedure-related complications within 1 month post-procedure(1 month)
研究者
研究点 (1)
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