NCT03123367已完成不适用
An Evaluation of the Safety and TechnIcal Feasibility Of the NelLa Women's Care Line for Female Gynecological ExaminaTions and Procedures (VIOLET)
Ceek Enterprises2 个研究点 分布在 1 个国家目标入组 154 人开始时间: 2017年3月6日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 154
- 试验地点
- 2
- 主要终点
- Technical Feasibility
研究概览
简要总结
Evaluation of the Nella Women's Care Line
详细描述
The Nella Women's Care Line is being studied in women undergoing a gynecological exam and other gynecological procedures that require visibility and access to the cervix.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •General inclusion criteria (applies to all study groups):
- •Subject is female
- •Subject is 18 - 65 years of age, inclusive, at the time of consent
- •Subject is undergoing a gynecological examination (as defined above) as part of their regular clinical care
- •Subject has undergone one or more prior gynecological exams
- •Subject is willing and able to provide written informed consent
- •Subject is able and willing to perform the functions required by the study protocol
排除标准
- •(applies to all study groups):
- •Subject has undergone hysterectomy
- •Subject has a known history of allergies to latex or plastics
- •Subject is pregnant
- •Subject is post-partum (≤ 12 weeks)
- •Subject has had an induced or spontaneous abortion in the prior 12 weeks
- •Subject has an active gynecologic complaint that, in the opinion of the clinician, would confound study results
- •Subject has dyspareunia
- •Subject has a known history of vulvodynia such as vulvular vestibular syndrome
- •Subject has a known history of vaginismus
- •Subject has a planned surgical procedure along with the gynecological exam
- •Subject is under incarceration
- •Subject is unable to provide written informed consent
- •Device specific inclusion criteria:
- •In addition to the general inclusion, the subject must meet all device specific criteria associated with their assignment group. Below are device-specific criteria. There is no device-specific exclusion criterion.
- •Nella VuSleeve (Group 1) inclusion:
- •Subject has a BMI ≥ 30 and/or 3 or more vaginal births
- •NellaSpec (Group 2), Nella NuSpec (Group 3), and Nella Insert (Group 4) inclusion:
- •Subject has a BMI < 35
研究组 & 干预措施
Group 1: Nella VuSleeve
Active Comparator
Sleeve
干预措施: Group 1: Nella VuSleeve (Device)
Group 2: Nella NuSpec
Active Comparator
Speculum
干预措施: Group 2: Nella NuSpec (Device)
Group 3: NellaSpec
Active Comparator
Speculum
干预措施: Group 3: NellaSpec (Device)
Group 4: Nella Insert
Active Comparator
Sleeve
干预措施: Group 4: Nella Insert (Device)
结局指标
主要结局
Technical Feasibility
时间窗: Day of Exam or Procedure
Cervical visualization and access
次要结局
- Safety(Day of Exam or Procedure)
研究者
研究点 (2)
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