Evaluation of the Safety of NovaSure in the Presence of Essure Following the Essure Confirmation Test (ECT) Post-Approval Study
试验速览
- 阶段
- 不适用
- 入组人数
- 318
- 试验地点
- 14
- 主要终点
- Rate of Essure micro-insert removal with NovaSure device
研究概览
简要总结
This post approval, observational study is being conducted to further evaluate the safety of the NovaSure Endometrial Ablation System when it is performed in the presence of Essure micro-inserts.
详细描述
A prospective, single arm, multi-center, post approval study that is designed to provide additional information on the safety of performing a NovaSure Impedence Controlled Endometrial Ablation System in the presence of Essure Permanent Birth Control System, following the Essure Confirmation Test has confirmed both bilateral tubal occlusion and the satisfactory location of the Essure micro-inserts. The study will be conducted at up to 15 clinical sites and enroll 318 patients. Patients who meet the inclusion and none of the exclusion criteria will have the study explained to them and be invited to participate. Enrolled subjects will have baseline data collected at the time of their NovaSure procedure and will be followed for 1 month after the NovaSure procedure to be assessed for adverse events.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Subject is 18 years of age or older and premenopausal.
- •Subject's gynecological history supports the use of NovaSure endometrial ablation for the treatment of menorrhagia.
- •Subject has had an Essure Permanent Birth Control System procedure.
- •The Essure Confirmation Test has confirmed both bilateral tubal occlusion and satisfactory placement of the Essure micro-inserts. A written report or ECT radiologic films need to be provided by the physician who performed the ECT. If neither is available, the ECT must be repeated prior to enrollment.
- •Subject is able to provide informed consent
排除标准
- •Subject has known or suspected endometrial carcinoma (uterine cancer) or pre-malignant conditions of the endometrium, such as unresolved (atypical) adenomatous hyperplasia.
- •Subject has abnormal/obstructive uterine cavity as confirmed by hysteroscopy or other imaging study (e.g. congenital malformation, large fibroid or large polyp)
- •Subject with any anatomic condition (e.g. history of previous classical cesarean section or transmural myomectomy) or pathologic condition (e.g. long term medical therapy) that could lead to weakening of the myometrium.
- •Subject has an active genital or urinary tract infection at the time of the procedure (e.g., cervicitis, vaginitis, endometritis, salpingitis, or cystitis).
- •Subject has an intrauterine device (IUD) currently in place.
- •Subject has active pelvic inflammatory disease or history of recent pelvic infection.
- •Subject has undiagnosed vaginal bleeding.
- •ECT unable to adequately assess bilateral tubal occlusion and proper micro-insert placement.
- •Subject has uterine sound measurement greater than 10 cm.
- •Subject with a uterine cavity length less than 4 cm.
- •Subject with a uterine cavity width less than 2.5 cm, as determined by the width dial of the disposable NovaSure device following device deployment.
- •Subject is unable to comply with the protocol and be available for follow up
- •In the opinion of the investigator, the subject has a medical condition that precludes safe participation in the study.
结局指标
主要结局
Rate of Essure micro-insert removal with NovaSure device
时间窗: NovaSure procedure visit (Day 1)
At the end of the NovaSure treatment and upon removal of the NovaSure device, the device will be directly observed to see if any Essure micro-insert(s) is(are) attached.
次要结局
- Number and percentage of subjects with adverse events(NovaSure Procedure visit (Day 1) and 1 month post NovaSure procedure)