Safety And Accuracy Study Of The Actisight™ Needle Guidance System In Patients Undergoing CT-Guided Procedures

A Prospective, Open-Label, Single-Arm, Single-Center Study Evaluating the Preliminary Safety and Accuracy of the ActiSight™ Needle Guidance System in Patients Undergoing CT-Guided Percutaneous Aspiration, Biopsy and RF Ablations

This will be a prospective, single-arm, single-center, open-label study to evaluate the preliminary safety and accuracy of the ActiSight™ Needle Guidance System in patients undergoing CT-guided percutaneous aspiration and RF Ablations The procedure will be performed by a trained physician. Subjects will be screened for inclusion in the study. Following signing of informed consent, screening procedures will be performed including demographic and medical history, vital signs, anthropometrics), chest radiography, if applicable and CT scanning, blood samples for coagulation indices (PT, APTT), if applicable, and pregnancy test in women of child-bearing potential.

Within an 18-day screening period, eligible subjects will be enrolled into the study and undergo percutaneous aspiration or percutaneous biopsy or RF ablation 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 chest aspiration if performed to detect the majority of post procedure pneumothoraces for biopsies in the chest. Post procedural CT will be performed according to the physician's consideration. ** Note ** If any complications are observed while using the ActiSight System, the investigator will revert to using standard procedure.

Study Overview

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

Detailed Description

Within an 18-day screening period, eligible subjects will be enrolled into the study and undergo percutaneous aspiration or percutaneous biopsy or RF ablation 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 chest aspiration if performed to detect the majority of post procedure pneumothoraces for biopsies in the chest. Post procedural CT will be performed according to the physician's consideration. ** Note ** If any complications are observed while using the ActiSight System, the investigator will revert to using standard procedure.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 4

Contacts and Locations

Study Locations

• Israel
  • Haifa, Israel
    • ActiViews Ltd

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 meeting all medical conditions for percutaneous aspiration/biopsy with safe path to lesion
• INR <1.4
• Written informed consent to participate in the study
• Ability to comply with the requirements of the study procedures

Exclusion Criteria:

• Hemophilia, thrombocytopenia, coagulopathy, or other elevated risk for bleeding or abnormal clotting
• Use of Aspirin or similar antithrombotic medication
• Pulmonary hypertension, heart failure, renal failure, or blood dyscrasia
• Subjects who cannot tolerate mild sedation

• Subjects with the following laboratory values, unless approved by hematologist:

  • Platelet count < 60,000/mL
  • APTT > 39 sec or PT > 15 sec, INR > 1.4
  • Pregnancy or lactation
  • Patient is unable to comply with requirements of the procedure, i.e. holding breath
  • Participation in an investigational trial within 30 days of enrollment
  • Any form of substance abuse (including drug or alcohol abuse), psychiatric disorder, or any chronic condition that could, in the opinion of the investigator, of interfering 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
Experimental: 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: 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: ActiSensor; ActiSticker

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Frequency of target reached (tip of the needle location) within a radius of 8 mm from the preplanned targeted point as measured on the final CT scan	During procedure

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of needle punctures through the skin	During procedure
Number of CT scans needed	During procedure

Collaborators and Investigators

• Sponsor: ActiViews Ltd.
• Investigators: Principal Investigator: Liat Appelbaum, Dr., Hadassah Ein Carem

Study record dates

Study Major Dates

• Study Start: June 1, 2010
• Primary Completion (Actual): January 1, 2012
• Study Completion (Actual): January 1, 2012

Study Registration Dates

• First Submitted: December 29, 2009
• First Submitted That Met QC Criteria: December 29, 2009
• First Posted (Estimate): December 30, 2009

Study Record Updates

• Last Update Posted (Estimate): July 12, 2012
• Last Update Submitted That Met QC Criteria: July 10, 2012
• Last Verified: July 1, 2012

More Information

Terms related to this study

• Other Study ID Numbers: ASNG-LFNA-101-IL-H