Suspended

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

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

Acessa Procedure

+ Acessa Procedure

Device
Who is being recruted

Neoplasms+2

+ Neoplasms by Histologic Type

+ Neoplasms, Muscle Tissue

From 18 to 55 Years
+4 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Other Study

Interventional
Study Start: April 2013
See protocol details

Summary

Principal SponsorAcessa Health, Inc.
Last updated: August 18, 2017
Sourced from a government-validated database.Claim as a partner

Study start date: April 1, 2013

Actual date on which the first participant was enrolled.

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.

Principal SponsorAcessa Health, Inc.
Last updated: August 18, 2017
Sourced from a government-validated database.Claim as a partner

Protocol

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

18 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Other Study

Some studies explore topics that don't fall into a specific category. These might include innovative research, new technologies, or emerging healthcare areas.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Female

Biological sex of participants that are eligible to enroll.

From 18 to 55 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

NeoplasmsNeoplasms by Histologic TypeNeoplasms, Muscle TissueNeoplasms, Connective and Soft TissueLeiomyoma

Criteria

3 inclusion criteria required to participate
Are capable of providing informed consent

Are planning to undergo the Acessa procedure

Are willing and able to comply with all procedures

1 exclusion criteria prevent from participating
In the medical judgement of the investigator should not participate in this study

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Acessa Procedure without the use of Targeting Animation Guidance

Group II

Acessa Procedure with Targeting Animation Guidance

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Donald I Galen Consulting

San Ramon, United StatesOpen Donald I Galen Consulting in Google Maps
SuspendedOne Study Center