Post Market Evaluation of Acessa With TAG

Not Applicable

Terminated

• Conditions: Uterine Fibroids
• Interventions: Device: Acessa Procedure

• Registration Number: NCT01842789
• Lead Sponsor: Acessa Health, Inc.

Brief Summary

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

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 Timeline

• Study Start: 2013-04
• Study First Submitted: 2013-04-17
• Study First Submitted QC: 2013-04-25
• Study First Posted: 2013-04-30
• Status Verified: 2016-02
• Primary Completion: 2016-02
• Study Completion: 2016-02
• Results First Submitted: 2017-05-27
• Results First Submitted QC: 2017-06-21
• Last Update Submitted: 2017-07-18
• Results First Posted: 2017-07-19
• Last Update Posted: 2017-08-18

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 18

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Acessa Procedure with TAG	Acessa Procedure	Acessa Procedure with Targeting Animation Guidance
Acessa Procedure w/o TAG	Acessa Procedure	Acessa Procedure without the use of Targeting Animation Guidance

Primary Outcome Measures

Name	Time	Method
Physician Feedback Regarding TAG System Use During Surgery.	Physicians have up to 1 hour after the procedure to fill out the questionnaire	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.
Number of Minutes From Visualizing the Target to Reaching the Target	Intraoperative	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.

Secondary Outcome Measures

Name	Time	Method
Recovery Time	1 to 2 months	Patients to be followed for 1 to 2 months post-treatment to evaluate recovery.

Trial Locations

Locations (1)

Donald I Galen Consulting; 🇺🇸 San Ramon, California, United States