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

Lung Diseases Clinical Trial

— ASNG  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01148706
• Other study ID #: ASNG-LFNA-103-IL
• Status: Completed
• Phase: Phase 4
• First received: June 20, 2010
• Last updated: December 9, 2012
• Start date: July 2010
• Est. completion date: September 2012

Study information

• Verified date: December 2012
• Source: ActiViews Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Liver Diseases
• Lung Diseases

Intervention

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.

Locations

Country	Name	City	State
Israel	Carmel Medical Center	Haifa

Sponsors (1)

Lead Sponsor	Collaborator
ActiViews Ltd.

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of CT scans performed during the procedure, from needle insertion to final needle position in the target lesion		1 Hour- During the procedure	No
Secondary	Procedure time (needle dwell time in the body)		1 hour -duration of the procedure	No