Post Market Evaluation of Acessa With TAG (TAG)

July 18, 2017 updated by: Acessa Health, Inc.

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).

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

18

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Ramon, California, United States, 94583
        • Donald I Galen Consulting

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Acessa Procedure w/o TAG
Acessa Procedure without the use of Targeting Animation Guidance
Device: Acessa Procedure
Acessa Procedure
Other Names:
  • Halt Procedure
  • GFA
  • TAG
Other: Acessa Procedure with TAG
Acessa Procedure with Targeting Animation Guidance
Device: Acessa Procedure
Acessa Procedure
Other Names:
  • Halt Procedure
  • GFA
  • TAG

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Physician Feedback Regarding TAG System Use During Surgery.
Time Frame: Physicians have up to 1 hour after the procedure to fill out the questionnaire
Physician preference testing is assessed by the completion of a questionnaire using a 5 point rating system ranging from "strongly agree" (a rating of 5) to "strongly disagree" (a rating of 1) regarding the use of the TAG system. The questions included are in regards to ease of targeting, ease of visualizing the target, the addition of specific features that enhance user interface and the overall set-up.
Physicians have up to 1 hour after the procedure to fill out the questionnaire
Number of Minutes From Visualizing the Target to Reaching the Target
Time Frame: Intraoperative
To measure difference in time to target with and without the use of TAG. This is a time and motion study, with time measured at each stage of the procedure. The most important subject variable to consider was number of fibroids targeted, which influenced overall procedure time.
Intraoperative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recovery Time
Time Frame: 1 to 2 months
Patients to be followed for 1 to 2 months post-treatment to evaluate recovery.
1 to 2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Acessa Health, Inc.

Investigators

  • Principal Investigator: Donald I Galen, MD, Donald I Galen Consulting

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2013

Primary Completion (Actual)

February 1, 2016

Study Completion (Actual)

February 1, 2016

Study Registration Dates

First Submitted

April 17, 2013

First Submitted That Met QC Criteria

April 25, 2013

First Posted (Estimate)

April 30, 2013

Study Record Updates

Last Update Posted (Actual)

August 18, 2017

Last Update Submitted That Met QC Criteria

July 18, 2017

Last Verified

February 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CP-00-0021

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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