Post Market Evaluation of the Acessa System With Targeting Animation Guidance (TAG)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- Physician Feedback Regarding TAG System Use During Surgery.
研究概览
简要总结
The purpose of this study is to test both user preference and speed of targeting with the use of the Acessa System with Targeting Animation Guidance (TAG).
详细描述
The intent of the TAG system is to assist the gynecologist in getting the tip of the Acessa Handpiece to the fibroid by creating an animated image overlay of the movements and placement.
The study will be conducted in two parts:
Part 1: User Preference Testing - users will be presented with various statements pertaining to the features of the system and asked to indicate their degree of agreement.
Part 2: Time to target - will be measure by fibroid.
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 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Are planning to undergo the Acessa procedure
- •Are willing and able to comply with all procedures
- •Are capable of providing informed consent
排除标准
- •In the medical judgement of the investigator should not participate in this study
研究组 & 干预措施
Acessa Procedure w/o TAG
Acessa Procedure without the use of Targeting Animation Guidance
干预措施: Acessa Procedure (Device)
Acessa Procedure with TAG
Acessa Procedure with Targeting Animation Guidance
干预措施: Acessa Procedure (Device)
结局指标
主要结局
Physician Feedback Regarding TAG System Use During Surgery.
时间窗: Physicians have up to 1 hour after the procedure to fill out the questionnaire
Physician preference testing is assessed by the completion of a questionnaire using a 5 point rating system ranging from "strongly agree" (a rating of 5) to "strongly disagree" (a rating of 1) regarding the use of the TAG system. The questions included are in regards to ease of targeting, ease of visualizing the target, the addition of specific features that enhance user interface and the overall set-up.
Number of Minutes From Visualizing the Target to Reaching the Target
时间窗: Intraoperative
To measure difference in time to target with and without the use of TAG. This is a time and motion study, with time measured at each stage of the procedure. The most important subject variable to consider was number of fibroids targeted, which influenced overall procedure time.
次要结局
- Recovery Time(1 to 2 months)