Post Market Evaluation of Acessa With TAG

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

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

Conditions
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Uterine Fibroids

Intervention / Treatment
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* Device: Acessa Procedure


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women who: Are planning to undergo the Acessa procedure Are willing and able to comply with all procedures Are capable of providing informed consent Exclusion Criteria: Women who: In the medical judgement of the investigator should not participate in this study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Acessa Procedure w/o TAG<br>Acessa Procedure without the use of Targeting Animation Guidance | Device: Acessa Procedure<br>* Acessa Procedure<br>* Other names: GFA;|
| Other: Acessa Procedure with TAG<br>Acessa Procedure with Targeting Animation Guidance | Device: Acessa Procedure<br>* Acessa Procedure<br>* Other names: GFA;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | Intraoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recovery Time | Patients to be followed for 1 to 2 months post-treatment to evaluate recovery. | 1 to 2 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acessa, Fibroids, Halt, Targeting Animation, Image Overlay, Radiofrequency Ablation, RFA