Post Market Evaluation of Acessa With TAG
| Status: | Terminated |
|---|---|
| Conditions: | Cervical Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - 55 |
| Updated: | 4/21/2016 |
| Start Date: | April 2013 |
| End Date: | February 2016 |
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).
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.
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.
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
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