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

Phase 4

Completed

• Conditions: Lung Diseases; Liver Diseases
• Interventions: Device: ActiSight Needle Guidance System

• Registration Number: NCT01148706
• Lead Sponsor: ActiViews Ltd.

Brief Summary

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

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 Timeline

• Study First Submitted: 2010-06-20
• Study First Submitted QC: 2010-06-21
• Study First Posted: 2010-06-22
• Study Start: 2010-07
• Primary Completion: 2012-09
• Study Completion: 2012-09
• Status Verified: 2012-12
• Last Update Submitted: 2012-12-09
• Last Update Posted: 2012-12-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ActiSight Needle Guidance System	ActiSight Needle Guidance System	-

Primary Outcome Measures

Name	Time	Method
Number of CT scans performed during the procedure, from needle insertion to final needle position in the target lesion	1 Hour- During the procedure

Secondary Outcome Measures

Name	Time	Method
Procedure time (needle dwell time in the body)	1 hour -duration of the procedure

Trial Locations

Locations (1)

Carmel Medical Center; 🇮🇱 Haifa, Israel