The Use of the ActiSight™ Needle Guidance System in Patients Undergoing CT-Guided With Lesions Smaller Than 15 mm (ActiSight)

A Prospective, Open-Label, Single-Arm, Single-Center Study Evaluating the Use of the ActiSight™ Needle Guidance System in Patients Undergoing CT-Guided Percutaneous Chest Aspiration and Biopsy With Lesions Smaller Than 15 mm

This will be a prospective, single-arm, single-center, open-label study to evaluate the use of the ActiSight™ Needle Guidance System in patients with lung lesions smaller than 15 mm undergoing CT-guided percutaneous chest aspiration.

Target location will be in the chest area; the procedure will be performed by a trained physician.

Study Overview

• Status: Completed
• Conditions: Cancer
• Intervention / Treatment: Device: ActiSight™ Needle Guidance System

Detailed Description

Subjects who are scheduled for clinically indicated percutaneous chest aspiration/biopsy procedures will be screened for inclusion in the study.

Within an 18-day screening period, eligible subjects will be enrolled into the study and undergo percutaneous chest aspiration or percutaneous biopsy utilizing the ActiSight™ Needle Guidance system using CT to guide the needle. Subjects will be followed-up for at least one hour at the clinic for safety and preliminary accuracy evaluations. An erect chest radiograph will be performed within 90 minutes of observation after the chest aspiration to detect the majority of post procedure pneumothoraces. A follow-up visit will be conducted within 7-10 days after the procedure day for safety evaluations.

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Phase 4

Participation Criteria

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 scheduled for clinically indicated percutaneous chest aspiration/biopsy procedures
• Subjects with lung lesions less than 15 mm.
• Written informed consent to participate in the study
• Ability to comply with the requirements of the study procedures

Exclusion Criteria:

• Subjects who cannot tolerate mild sedation
• Subjects who participated in an active stage of any drug, intervention or treatment trial within 30 days of enrollment.
• Subjects with preexisting conditions which, in the opinion of the investigator, interfere with the conduct of the study.
• Subjects who are uncooperative or cannot follow instructions

Study Plan

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: ActiSight™ Needle Guidance System; ActiSight™ Needle Guidance System is comprised of several sub-system components: a computer, a disposable ActiSensor optical sensor, and the disposable ActiSticker, which provides a reference for the insertion of the tool and for the camera.	Device: ActiSight™ Needle Guidance System; ActiSight™ Needle Guidance System is comprised of several sub-system components: a computer, a disposable ActiSensor optical sensor, and the disposable ActiSticker, which provides a reference for the insertion of the tool and for the camera.; Other Names: ActiSight System

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency of adequate sample for diagnosis obtained in the procedure as determined from the Histology / Cytology report	Frequency of adequate sample for diagnosis obtained in the procedure as determined from the Histology / Cytology report	6 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency of target reached by the biopsy or aspiration tool, as determined by a qualified physician reviewing the CT images	Frequency of target reached by the biopsy or aspiration tool, as determined by a qualified physician reviewing the CT images	6 month
Number of needle punctures through the skin	Number of needle punctures through the skin	6 month
Number of needle punctures through the pleura	Number of needle punctures through the pleura	6 month
Number of CT scans needed	Number of CT scans needed	6 month
Duration of procedure: patient preparation, planning, guidance and Cytolog report.	Duration of procedure: patient preparation, planning, guidance and Cytolog report.	6 month

Collaborators and Investigators

• Sponsor: ActiViews Ltd.
• Collaborators: Tel-Aviv Sourasky Medical Center
• Investigators: Principal Investigator: Boaz Tiran, Dr., Tel-Aviv Sourasky Medical Center

Study record dates

Study Major Dates

• Study Start: June 1, 2009
• Primary Completion (Actual): January 1, 2010
• Study Completion (Actual): January 1, 2010

Study Registration Dates

• First Submitted: March 17, 2011
• First Submitted That Met QC Criteria: March 17, 2011
• First Posted (Estimate): March 18, 2011

Study Record Updates

• Last Update Posted (Estimate): October 3, 2012
• Last Update Submitted That Met QC Criteria: October 2, 2012
• Last Verified: October 1, 2012

More Information

Terms related to this study

• Keywords: cancer
• Other Study ID Numbers: ASNG-LFNA-102-IL; ASNG-LFNA-101-IL (Other Identifier: Protocol #)