NL-OMON39138已完成不适用
Symptom Effectiveness Study of VizAblate® Intrauterine Ultrasound-Guided RF Ablation (IUUSgRFA) in the Ablation of Large Uterine Fibroids - Fibroid Ablation Study - Large Fibroids (FAST-L)
Gynesonics0 个研究点目标入组 24 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 24
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •(a) 28 years of age or older
- •(b) Consistent menstrual cycles between 22-35 days
- •(c) History of excessive bleeding for at least 3 months
- •(d) Baseline UFS-QOL SSS score >= 20
- •(e) At least one Target Fibroid having a maximum diameter > 5 cm and
- •(f) Total Target Fibroid Score <= 45
- •(g) Subject is not at material risk for pregnancy (not sexually active, does not have a male partner or is in a monogamous relationship with a sterilized male partner, using reliable oral or barrier contraception, intrauterine device (IUD) or the levonorgestrel intrauterine system (LNG-IUS) in accordance with the package insert). Subject is willing to maintain use or non-use of hormonal contraception uniformly from 3 months pre-study through the 12-month follow-up period. Only monthly cyclic combined contraceptive steroids will be acceptable as oral contraception.
- •(h) Willingness to participate in the study, to adhere to all study follow-up requirements, and to sign the informed consent form
- •(i) Subject is willing to have uniform maintenance (use or non-use) of any antifibrinolytic or nonsteroidal anti-inflammatory agents (COX inhibitors) for excessive vaginal bleeding for 2 months pre-study through the 12-month follow-up period
- •(j) Menstrual Pictogram score >= 120 during a one-month screening period.
排除标准
- •(a) Presence of type 0 intracavitary fibroids
- •(b) Any Target Fibroid > 10 cm in maximum diameter
- •(c) Any abnormality of the endometrial cavity that, in the judgment of the investigator, obstructs access of the VizAblate Handpiece to the endometrial cavity.
- •(d) Postmenopausal by history
- •(e) Desire for current or future fertility
- •(f) Hemoglobin < 6 g/dl (3.7 mmol/L)
- •(g) Pregnancy, as determined by urine hCG obtained within 24 hours prior to VizAblate procedure
- •(h) Evidence of disorders of hemostasis
- •(i) Use of GnRH agonist or depomedroxyprogesterone acetate or other implantable or injectable progestin and/or estrogen, SERM or SPRM within the last 6 months prior to completion of screening UFS-QOL.
- •(j) Evidence for current cervical dysplasia (CIN II or greater)
- •(k) Endometrial hyperplasia
- •(l) Confirmed abdominal / pelvic malignancy within the previous five years
- •(m) Active pelvic infection (e.g., active salpingitis or other pelvic inflammatory disease) or positive screening for pelvic gonorrhea or chlamydia
- •(n) Clinically significant adenomyosis
- •(o) Previous uterine artery embolization
- •(p) Previous surgical or ablative treatment for fibroids or menorrhagia within 12 months prior to completion of the screening UFS-QOL.
- •(q) Current use of anticoagulant therapy
- •(r) Need for emergency surgery to treat fibroid symptoms
- •(s) Major medical or psychiatric illness affecting general health or subject*s ability to adhere to the follow-up schedule or provide valid subject self-assessment data
- •(t) Contraindication to MRI, including allergy to contrast media or claustrophobia
- •(u) Renal insufficiency [serum creatinine >= 1.5 mg/dL (132.6 µmol/L)]]
- •(v) Uncontrolled hypertension lasting 2 years or more (systolic blood pressure >= 140 mm Hg and/or diastolic blood pressure >= 90 mm Hg that is not controlled with an antihypertensive drug regimen)
- •(w) One or more treatable fibroids that are calcified
- •(x) Chronic pelvic pain (disruptive for at least six months)
- •(y) Presence of an extrauterine pelvic mass
- •(z) Presence of a tubal implant for sterilization
- •(aa) Previous pelvic irradiation
- •(bb) Endometrial cavity length < 4.5 cm
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