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

Study Purpose and Objectives

Until recently, electromagnetic needle tracking has not been applied in the field of gynecology. The use of electromagnetic needle tracking system with standard ultrasound imaging may enhance the surgeon’s ease and speed of placement of an Acessa handpiece during fibroid ablation cases. This guidance system, called Targeting Animation System (TAG) tracks the surgeon’s hand movements that guide both the tip of the handpiece and the ultrasound then creates an animated view. The TAG system is an optional accessory that can be turned on or off during the application of the Acessa System. The Acessa procedure remains unchanged; the physician will simply have additional information as to the relation between the Acessa Handpiece and ultrasound transducer. The ultrasound image remains the primary mode used to map and locate fibroids.

The purpose of this study is to test both user preference and speed of targeting when combining the TAG system with the Acessa System which has been cleared for the treatment of uterine fibroids. Objective

  • Group 1: 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 consist of the non-randomized treatment of 15 subjects without TAG and treatment of 15 subjects with TAG. Users will be asked various qualitative questions concerning their experience both with and without TAG .
  • Group 2: To measure difference in time to target with and without TAG – this will consist of the treatment of 15-20 subjects where the use of the TAG system will be randomized by fibroid. Time to target will be measured by fibroid. Subjects will be followed for 30 days post treatment to evaluate recovery.

Study Design

This is a post-market, prospective, non-significant risk, observational, multi-center study designed to obtain user preference data and comparative time to target data with and without TAG. Subjects will be recruited into one of two groups:

Group 1) consists of 15 Acessa patients with TAG and 15 Acessa patients without TAG. Non-randomized.

Group 2) consists of 15 - 20 Acessa patients with fibroids randomized to TAG on/off. This is a time and motion study, with time measured from puncture of the serosal surface to the fibroid capsule.

Endpoints

Primary Endpoints of this study are:

  • Physician interface and preference with and without TAG
  • Time to target and duration of treatment

Secondary Endpoint:

  • Recovery time

Inclusion Criteria: Women who:

  1. Are planning to undergo the Acessa procedure
  2. Are willing and able to comply with all procedures
  3. Are capable of providing informed consent

Exclusion Criteria: Women who:

  1. In the medical judgment of the investigator should not participate in this study

If you are interested in referring a patient to this or other Halt Medical post-market studies, please contact Angie Avila, Clinical Research Associate at 925-348-9909 or refer to www.clinicaltrials.gov where you will find a list of all ongoing studies using the Acessa System.

 

ClinicalTrials.gov Identifier:
NCT01842789
http://clinicaltrials.gov/ct2/show?term=acessa&rank=1

LI-00-0212-C