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Acessa Procedure without the use of Targeting Animation Guidance

Acessa Procedure with Targeting Animation Guidance

Acessa Procedure

Donald I Galen, MD

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.

Post Market Evaluation of Acessa With TAG

Post Market Evaluation of the Acessa System With Targeting Animation Guidance (TAG)

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.

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.

Patients to be followed for 1 to 2 months post-treatment to evaluate recovery.

Acessa Health, Inc.

Acessa Procedure without the use of Targeting Animation Guidance

Acessa Procedure: Acessa Procedure

Acessa Procedure w/o TAG

Acessa Procedure with Targeting Animation Guidance

Acessa Procedure: Acessa Procedure

Acessa Procedure With TAG

Total

Age, Continuous

Sex: Female, Male

Laura Kemp, Clinical Affairs Consultant

Transducer and handpiece dynamic animation was

The use of TAG enabled the ability to reach the fi

Knowing the handpiece trajectory helped to tar

The transducer and handpiece dynamic animation hel

The use of TAG provided confidence when targeting

All subjects in whom TAG was used as an accessory system. This outcome measure was specific to this arm of the study only. Physicians provided feedback regarding use of the accessory system but did not provide feedback regarding the standard system without guidance. Physicians rated the system on a scale of 1 Strongly disagree to 5 Strongly agree.

Physician Feedback Regarding TAG System Use During Surgery.

All participants undergoing treatment with Acessa (with or without targeting animation guidance).

Number of Minutes From Visualizing the Target to Reaching the Target

All subjects followed for 1 to 2 months post treatment.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Post Market Evaluation of Acessa With TAG	NCT01842789	Uterine Fibroid...	Acessa Procedur...	18 Years - 55 Years	Acessa Health, Inc.
Post Market Evaluation of Acessa With TAG	NCT01842789	Uterine Fibroid...	Acessa Procedur...	18 Years - 55 Years	Acessa Health, Inc.

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