Clinical trial NCT01842789: Post Market Evaluation of Acessa With TAG
Official title: Post Market Evaluation of the Acessa System With Targeting Animation Guidance (TAG)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Uterine Fibroids
Keywords: Acessa
Fibroids
Halt
Targeting Animation
Image Overlay
Radiofrequency Ablation
RFA
Lead sponsor: Acessa Health, Inc.
Sponsor class: INDUSTRY
First posted: 2013-04-30
Enrollment: 18
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Physician Feedback Regarding TAG System Use During Surgery.
timeFrame: Physicians have up to 1 hour after the procedure to fill out the questionnaire
measure: Number of Minutes From Visualizing the Target to Reaching the Target
timeFrame: Intraoperative
Secondary outcomes:
measure: Recovery Time
timeFrame: 1 to 2 months
Other outcomes:
Locations:
city: San Ramon
country: United States
facility: Donald I Galen Consulting
state: California
Study officials:
affiliation: Donald I Galen Consulting
name: Donald I Galen, MD
role: PRINCIPAL_INVESTIGATOR
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