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).
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
18
Acessa Procedure
Donald I Galen Consulting
San Ramon, California, United States
Physician Feedback Regarding TAG System Use During Surgery.
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.
Time frame: Physicians have up to 1 hour after the procedure to fill out the questionnaire
Number of Minutes From Visualizing the Target to Reaching the Target
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.
Time frame: Intraoperative
Recovery Time
Patients to be followed for 1 to 2 months post-treatment to evaluate recovery.
Time frame: 1 to 2 months
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