Uterine Fibroids Clinical Trial
Official title:
Post Market Evaluation of the Acessa System With Targeting Animation Guidance (TAG)
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label
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