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


N/A
18 Years
55 Years
Open (Enrolling)
Female
Uterine Fibroids

Thank you

Trial Information

Post Market Evaluation 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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Outcome Measure:

Physician interface and preference with and without TAG

Outcome Description:

To obtain feedback on the user interface of the Acessa System with TAG through physician preference testing using a direct, observable human model. This will be assessed by the completion of a questionnaire using a 5 point rating system ranging from "strongly agree" to "strongly disagree" regarding the ease of targeting, specific features of the system, user interface and set-up.

Outcome Time Frame:

Up to 1 hour post-treatment

Safety Issue:

No

Principal Investigator

Donald I Galen, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Donald I Galen Consulting

Authority:

United States: Food and Drug Administration

Study ID:

CP-00-0021

NCT ID:

NCT01842789

Start Date:

April 2013

Completion Date:

December 2014

Related Keywords:

  • Uterine Fibroids
  • Acessa
  • Fibroids
  • Halt
  • Targeting Animation
  • Image Overlay
  • Leiomyoma
  • Myofibroma

Name

Location
Donald I Galen Consulting San Ramon, California  94583