NCT01842789

Post Market Evaluation of Acessa With TAG

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Acessa Health, Inc. · Industry
• Sex: Female
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Uterine Fibroids

Interventions

Type	Name	Description
DEVICE	Acessa Procedure	Acessa Procedure

Timeline

• Start date: 2013-04-01
• Primary completion: 2016-02-01
• Completion: 2016-02-01
• First posted: 2013-04-30
• Last updated: 2017-08-18
• Results posted: 2017-07-19

Locations

1 site across 1 country: United States