A Pivotal Study of Doppler Guided Uterine Artery Occlusion as Treatment for the Reduction of Fibroid Associated Bleeding
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 87
- 试验地点
- 22
- 主要终点
- No Surgical Re-intervention
研究概览
简要总结
The objective of this study is to evaluate the safety and effectiveness of Doppler guided uterine artery occlusion (D-UAO) for the reduction of fibroid associated bleeding.
详细描述
The GYNECARE GYNOCCLUDE D-UAO Instruments are single-use disposable instruments consisting of a GYNECARE GYNOCCLUDE Uterine Stabilizer, a GYNECARE GYNOCCLUDEM Introducer Sheath, a GYNECARE GYNOCCLUDE Doppler Clamp, and a GYNECARE GYNOCCLUDE Coupler.
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
- •25 to 50 years of age;
- •PBLAC score of 150 or greater;
- •Completed child-bearing;
- •Normal Pap smear within 12 months;
- •Cervix suitable for tenaculum placement as determined by pelvic exam;
- •At least one uterine fibroid of 3 cm diameter or greater with a prevailing pathology (e.g., as opposed to adenomyosis) of fibroids determined through ultrasound;
- •Willing to maintain use or non-use of hormonal contraception from 3 months pre-study throughout the 12-month follow-up period;
- •Willing to maintain use or non-use of anti-fibrinolytic agents from 3 months pre-study throughout the 12-month follow-up period;
- •Able to tolerate the required prolonged supine position during treatment (approximately 6 hours);
- •Willing and able to provide informed consent and to follow study-related requirements;
排除标准
- •Pregnancy (as confirmed immediately prior to procedure)
- •Fibroid diameter greater than 8.0 cm determined through transvaginal ultrasound; [or if 2 dimensions are measured, total dimension greater than 16 cm; or if the 3 dimensions (length, height, width) are measured, total dimension greater than 24 cm];
- •Presence of a pedunculated fibroid determined by ultrasound; hysteroscopy, or saline infused sonography;
- •Hydronephrosis as determined by radiologist interpretation on renal ultrasound pre-procedurally;
- •Menopausal;
- •Clinical history of any thromboembolic disease;
- •Blood urine nitrogen (BUN) greater than 20 mg/dL and/or serum creatinine greater than 1.2 mg/dL unresolved with change in diet or hydration; · One or more lower uterine segment fibroids determined through pelvic exam;
- •History of gynecologic malignancy, atypical endometrial hyperplasia, or pelvic inflammatory disease;
- •Abnormal endometrial biopsy within the last 6 months prior to procedure;
- •Pelvic mass outside the uterus suggesting other disease processes;
- •Any current acute or chronic systemic infection or localized pelvic infection, including an unresolved urinary tract infection;
- •Using GnRH agonist or mifepristone within 6-months prior to the start of the study;
- •An intrauterine device (IUD) in place;
- •Using anticoagulation therapy (except OTC treatments (e.g. aspirin)), or have an underlying bleeding disorder;
- •Unsuitable for MRI examination, if within study subgroup to undergo MRI evaluation (e.g. severe claustrophobia, non-MRI-compatible implanted metalloid devices);
- •Prior endometrial ablation, uterine artery embolization, or uterine artery ligation;
- •Poor procedural candidate due to medical conditions as determined by the investigator (e.g. anesthesia class, renal insufficiency, heart disease);
- •Grade 1 for 3D Color Doppler or no flow observed for cystoscopy on ureter flow assessment if applicable.
研究组 & 干预措施
DUAO Device
Doppler-guided uterine artery occlusion device (Single-arm study)
干预措施: Doppler-Guided Uterine Artery Occlusion Device (DUAO) (Device)
结局指标
主要结局
No Surgical Re-intervention
时间窗: Study completion
Number of participants without any subsequent surgical procedure intended to manage fibroid symptoms performed. Potential procedures included surgical hysterectomy or dilatation and curettage (D\&C) for treatment of menorrhagia; uterine artery embolization (UAE) or laparoscopic uterine artery occlusion; endometrial resection or ablation; myomectomy or myolysis.
Improvement in Pictorial Blood Loss Assessment Chart (PBLAC) Score
时间窗: From baseline to 12 months
Number of participants with a 50% or greater reduction in PBLAC score from baseline at 12 mo and a PBLAC score of less than 250. PBLAC is a simple validated semiquantitative method of measuring total menstrual blood loss using a pictorial representation of blood loss, where higher scores indicate more blood loss. This hybrid endpoint combined the reduction in PBLAC score with the total PBLAC score.
次要结局
- Maintenance of Menses(12 months)
- Decrease in Fibroid Bulk(From baseline to 12-months)
- Mean Improvement in Health Related Quality of Life (HRQOL) Scores(From baseline to 12 months)
- Procedural Satisfaction(12 months)
- Mean Improvement in Uterine Fibroid Symptom Quality of Life (UFS-QOL) Symptom Severity Scores(From baseline to 12 months)