Post Market Evaluation 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
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.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label
Physician interface and preference with and without TAG
To obtain feedback on the user interface of the Acessa System with TAG through physician preference testing using a direct, observable human model. This will be assessed by the completion of a questionnaire using a 5 point rating system ranging from "strongly agree" to "strongly disagree" regarding the ease of targeting, specific features of the system, user interface and set-up.
Up to 1 hour post-treatment
Donald I Galen, MD
Donald I Galen Consulting
United States: Food and Drug Administration
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