NCT01140555终止不适用
A Pilot Study to Determine the Optimal Procedure Steps to Obtain and Maintain Bilateral Uterine Artery Occlusion Using the GYNECARE GYNOCCLUDE™ Doppler Guided Uterine Artery Occlusion Device in Women With Uterine Fibroids
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 4
- 主要终点
- Optimal procedural steps
研究概览
简要总结
This pilot study has a sequential design involving three groups to ensure appropriate development and evaluation of the optimal procedural steps of the D-UAO device and to confirm that those steps are reproducible in the hands of multiple surgeons.
详细描述
- Group 1 - beginning with the use of the current instructions for use (IFU) will have adjustments made as necessary to the D-UAO procedural steps for uterine artery occlusion confirmed by 2/3-D Power Colour Doppler ultrasound (2/3DPD).
- Group 2 - verify that optimal D-UAO IFU procedural steps generated in Group 1 as confirmed by 2/3DPD.
- Group 3 - verify that the optimal D-UAO procedural steps are reproducible in the hands of multiple surgeons in addition to the group 1 investigators, as confirmed by 2/3DPD.
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 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age 25-55 years with regular menses and at least one symptom related to uterine fibroids (for example heavy bleeding).
- •Completed child-bearing.
- •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 abdominal/transvaginal ultrasound.
- •Confirmation of the ability to clearly visualise bilateral uterine arteries with 2/3DPD.
- •Dominant fibroid (defined as >3cm in diameter) must be well vascularised as determined by CE-MRI (for Group 2 and 3 patients only).
- •Able to tolerate the required prolonged supine position during treatment (approximately 6 hours).
- •Cervix suitable for tenaculum placement as determined by pelvic exam.
- •Normal Pap smear within the last 36 months.
- •Agrees to participate in the study, and following review of the patient information sheet documents this agreement by signing the Ethics Committee approved informed consent.
排除标准
- •Prior endometrial ablation, uterine artery embolization, or uterine artery ligation.
- •Pregnancy (As confirmed by a urine pregnancy test at screening and immediately prior to procedure).
- •One or more lower uterine segment fibroids determined through pelvic exam which in the examiner's opinion would prevent proper clamp application.
- •Any known contraindications to the contrast agent to be used for the CE-MRI as determined by the study radiologist (for Group 2 and 3 patients only).
- •Pelvic mass outside the uterus suggesting other disease processes.
- •An intrauterine device (IUD) in place during the day of procedure.
- •Hydronephrosis as determined by interpretation of a pre-procedure renal ultrasound.
- •No ureteral jets observed on ultrasound prior to clamping.
- •Presence of a pedunculated fibroid determined by ultrasound, hysteroscopy, or saline infused sonography or CE MRI.
- •Any current acute or chronic systemic infection or localized pelvic infection, including an unresolved urinary tract infection.
- •Clinical history of any thromboembolic disease.
- •History of gynecologic malignancy, atypical endometrial hyperplasia, or pelvic inflammatory disease.
- •Using anticoagulation therapy (except OTC treatments, e.g. aspirin), or has a known underlying bleeding disorder.
- •In the investigator's opinion, any medical condition or psychiatric illness that could potentially be life threatening or affect their ability to complete the study visits according to this protocol.
研究组 & 干预措施
GYNECARE GYNOCCLUDE™
Experimental
GYNECARE GYNOCCLUDE™ Doppler Guided Uterine Artery Occlusion Device
干预措施: GYNECARE GYNOCCLUDE™ (Device)
结局指标
主要结局
Optimal procedural steps
时间窗: 6 hrs
Establish and verify optimal procedural steps to obtain and maintain bilateral uterine artery occlusion using the GYNECARE GYNOCCLUDE™ Doppler Guided Uterine Artery Occlusion Device (D-UAO) for 6 hours, and confirm that these optimal procedural steps are reproducible by multiple surgeons
次要结局
- Fibroid devascularization(Baseline and 1 month post procedure)
- Safety(Baseline through one month post procedure)
研究者
研究点 (4)
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