Assessment of Uterine Access, Uterine Patency and Intrauterine Adhesions (IUA) 3, 6 and 12 Months Following Endometrial Ablation: A Prospective Single-Center Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Incidence of Intrauterine Adhesions (IUA)
研究概览
简要总结
The objective of this study is to gain information concerning the acute and longer-term morphological changes within the uterus following endometrial ablation. Hysteroscopic evaluation of the uterine cavity will be used to determine if physical access and the ability to systematically assess the post-ablation uterine cavity were preserved. The presence, location and severity of intrauterine adhesions will be documented in participants who are 3, 6 and 12 months from their standard of care endometrial ablation.
详细描述
Prospective single center observational study. Up to 30 subjects will be enrolled (up to 10 subjects per time point). Patients who sign the Institutional Review Board (IRB) approved consent form who have undergone endometrial ablation within the prior 14 months from time of consent will be asked to participate in this study. Patients meeting all eligibility criteria will undergo either a 3, 6 or 12 month diagnostic second look hysteroscopy (SLH) as assigned by the Investigator depending on the duration of time between the ablation and the signature date of the informed consent (up to 10 subjects for each time point). A diagnostic SLH will be performed for scoring of intrauterine adhesions by the investigator and an independent reviewer. The ability to access the uterine cavity (or not) will be documented.
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
- 是
入选标准
- •Premenopausal female patients ≥ 18 years of age
- •Patient has undergone endometrial ablation within the prior 14 months.
- •There were no contraindications for endometrial ablation as specified in Ablation System labeling
- •Patient agrees to undergo an SLH either at 3, 6 or 12 months post-ablation
- •Patient abstained from any form of hormonal contraception including an IUD after the ablation and through the period that the SLH is performed.
- •Patient has signed the IRB approved informed consent.
排除标准
- •Additional intrauterine procedures performed between time of endometrial ablation and the SLH; e.g., endometrial and/or myometrial resection.
- •IUD in situ
- •Pregnant (positive urine pregnancy test) or lactating
- •Active sexually transmitted infection or genital infection, or other clinically significant active and/or systemic infection per clinical or laboratory examinations at the time of endometrial ablation procedure or second look hysteroscopy (e.g., cervicitis, vaginitis, endometritis, or salpingitis).
- •Systemic steroid within 1 week of endometrial ablation
- •Previous adhesiolysis procedure or diagnosis of Asherman's disease.
- •No noted clinically significant uterine anomalies at the time of the ablation (e.g., septate uterus or other anomalies that distorts the uterine cavity)
- •Any other condition that in the opinion of the investigator could represent an increased risk for the subject, affect the primary outcomes of this study and/or impact the subject's ability to comply with protocol requirements.
- •Participating or considering participation in a clinical trial of another investigational drug or device during this study
结局指标
主要结局
Incidence of Intrauterine Adhesions (IUA)
时间窗: 3, 6 or 12 months post-ablation
次要结局
未报告次要终点