Status:
TERMINATED
Post Market Evaluation of Acessa With TAG
Lead Sponsor:
Acessa Health, Inc.
Conditions:
Uterine Fibroids
Eligibility:
FEMALE
18-55 years
Phase:
NA
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 wi...
Eligibility Criteria
Inclusion
- 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
- Women who:
- In the medical judgement of the investigator should not participate in this study
Key Trial Info
Start Date :
April 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2016
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT01842789
Start Date
April 1 2013
End Date
February 1 2016
Last Update
August 18 2017
Active Locations (1)
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1
Donald I Galen Consulting
San Ramon, California, United States, 94583