Effectiveness of ActiSight™ Needle Guidance System in Patients Undergoing CT-Guided Procedures (ASNG)

December 9, 2012 updated by: ActiViews Ltd.

Phase IV Study of the ActiSight Needle Guidance System Which Assist in Guiding a Rigid Interventional Instrument Percutaneously, to a Designated Point Within the Body by Means of CT Visualization

To assist in guiding a rigid interventional instrument percutaneously, to a designated point within the body by means of CT visualization.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The ActiSight™ Needle Guidance System is an optical navigation system designed to assist physicians performing percutaneous interventions under CT guidance. The system allows the user to select an obstacle free path to a target lesion based on pre-procedure CT images, and then provides real-time information for guiding the interventional tool towards the target along the selected path.

The ActiSight™ Needle Guidance System employs a miniature video camera mounted on the needle and a reference pad attached to the skin to register the needle into the CT image space, and thus, track the needle advance towards the target. CT scans are used as needed to verify the location of the needle.

The primary objective of this study is to demonstrate the effectiveness of the ActiSight™ Needle Guidance System in assisting in CT-guided percutaneous procedures.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 4

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

  • Israel
      • Haifa, Israel
        • Carmel Medical Center

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male or female subjects, 18 years of age or older at the time of enrollment.
  • Subjects meeting all medical conditions for percutaneous CT guided. procedures in the chest, abdomen or pelvic, with safe path to lesion.
  • Written informed consent to participate in the study.
  • Ability to comply with the requirements of the study procedures.

Exclusion Criteria:

  • Having co-morbidities that would clinically preclude them from an image guided procedure as determined by the operating physician.
  • Significant coagulopathy that cannot be adequately corrected.
  • Patients who have a medical contraindication to sedation (Lidocaine allergy).
  • Pregnancy or lactation.
  • Participation in an investigational trial within 30 days of enrollment.

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: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ActiSight Needle Guidance System
Device: ActiSight Needle Guidance System
The ActiSight™ Needle Guidance System employs a miniature video camera mounted on the needle and a reference pad attached to the skin to register the needle into the CT image space, and thus, track the needle advance towards the target. CT scans are used as needed to verify the location of the needle.
Other Names:
  • ASNG=ActiSight Needle Guidance System

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of CT scans performed during the procedure, from needle insertion to final needle position in the target lesion
Time Frame: 1 Hour- During the procedure
1 Hour- During the procedure

Secondary Outcome Measures

Outcome Measure
Time Frame
Procedure time (needle dwell time in the body)
Time Frame: 1 hour -duration of the procedure
1 hour -duration of the procedure

Collaborators and Investigators

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

Sponsor

ActiViews Ltd.

Investigators

  • Principal Investigator: Natan Peled, Dr., Carmel MC

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

July 1, 2010

Primary Completion (Actual)

September 1, 2012

Study Completion (Actual)

September 1, 2012

Study Registration Dates

First Submitted

June 20, 2010

First Submitted That Met QC Criteria

June 21, 2010

First Posted (Estimate)

June 22, 2010

Study Record Updates

Last Update Posted (Estimate)

December 11, 2012

Last Update Submitted That Met QC Criteria

December 9, 2012

Last Verified

December 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ASNG-LFNA-103-IL

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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