Endocervical Curettage Performed With a Kevorkian Curette Versus Cytobrush in Patients With ASC-H, LSIL, ASCUS HPV Positive and Non-contributory Colposcopy (ZT3) Smear or Atypical Pap Smear With Positive HPV Test
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Percentage of sampling failures
研究概览
简要总结
The recommendations on the method and the realization of the cervico-uterine smears are clear. With regard to performing endocervical curettage, several methods are possible without precise consensus. In general, the Kevorkian curette is widely used. However, it is often reported by doctors and patients that curettage is painful. Some articles show that the cytobrush would be less painful. While keeping a percentage of correct curettage failures, it is sought to show that the cytobrush would improve the comfort of the patient during curettage.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women followed for a cervical pathology requiring endocervical curettage:
- •AGC type (glandular cell atypia) with positive HPV test
- •Frottis ASC-H, LSIL, ASCUS HPV + with non-contributive colposcopy (ZT3)
排除标准
- •Pregnant woman
- •Women under the age of 25 or over 65
- •Stenosis of the neck complete or tight not allowing the possible insertion of a curette (inadequate size cervical orifice and material)
- •Presence of a vaginal lesion on colposcopic examination
研究组 & 干预措施
Kevorkian curette
干预措施: Kevorkian curette (Device)
Cytobrush
干预措施: Cytobrush (Device)
结局指标
主要结局
Percentage of sampling failures
时间窗: once time, Baseline
Unsatisfactory sampling will be defined by a specimen containing \<20 endocervical cells, \<3 epithelial flaps, and one specimen without stroma.
次要结局
- Pain Assessment Using a Visual Analogue Scale (VAS)(once time, Baseline)