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

ActiViews Ltd.20 enrolled

Overview

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

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

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Lung Diseases Liver Diseases

Interventions

ActiSight Needle Guidance SystemDEVICE

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Carmel Medical Center

Haifa, Israel

Outcomes

Primary Outcomes

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

Secondary Outcomes

Procedure time (needle dwell time in the body)

Time frame: 1 hour -duration of the procedure

Data from ClinicalTrials.gov

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