Safety & Accuracy Study of the ActiSight Needle Guidance System in Patients Undergoing CT-Guided Percutaneous Chest Aspiration and Biopsy

NCT00819533 | Completed

• 1 other identifier: ASNG-LFNA-101-CAN
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This study is designed to evaluate preliminary safety and accuracy of the ActiSight™ Needle Guidance System in patients undergoing CT-guided lung aspiration or biopsy. This image guidance system uses a combination of CT scans and camera images to help guide a biopsy needle to a lung lesion. The system displays a simulated image of a biopsy needle and its estimated path for the biopsy.

Conditions

Biopsy

Outcome Measures

Primary Outcomes (1)

• Frequency of target reached within a radius of 5 mm from the preplanned targeted point as measured on the final CT scan

  Measure evaluated during entire course of study

Secondary Outcomes (3)

• Number of punctures required to obtain sample

  Measure evaluated during entire course of study

• Number of intermediate CT scans required to obtain sample

  During entire course of study

• An adequate sample obtained during the procedure

  during entire course of study

Study Arms (1)

sensor

EXPERIMENTAL

Patients will have their lung sample obtained under CT and ActiSight needle guidance system

Device: sensor (ActiSight™ Needle Guidance System)

Interventions

sensor (ActiSight™ Needle Guidance System) DEVICE

Patients will have their lung sample obtained under CT and ActiSight needle guidance system

sensor

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female subjects, 18 years of age or older at the time of enrollment
• Subjects meeting all medical conditions for percutaneous chest aspiration/biopsy with safe path to lesion between ribs, however, not in the breast area in women or men with gynecomastia
• Single target pulmonary lesion greater than 10 mm in size (diameter) and depth of lesion greater than 40 mm from the skin
• Written informed consent to participate in the study
• Ability to comply with the requirements of the study procedures

You may not qualify if:

• Fibrous tissue or cyst in access path (not including target lesion)
• Hemophilia, thrombocytopenia, coagulopathy, or other elevated risk for bleeding or abnormal clotting
• Use of ticlodipine or similar antithrombotic medication
• For subjects taking warfarin or other anticoagulant medication, INR \>1.3
• Pulmonary hypertension, heart failure, renal failure, or blood dyscrasia
• Patient is unable to comply with requirements of the procedure, i.e. holding breath
• Participation in any prior 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

Sponsors & Collaborators

• ActiViews Ltd.: lead

Study Sites (1)

University Health Network, Toronto General Hospital

Toronto, Ontario, Canada

Location

Study Officials

• Narinder Paul, MD

  University Health Network, Toronto General Hospital

  PRINCIPAL INVESTIGATOR

• Uri Shreter, Ph.D.

  ActiViews Ltd.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: January 8, 2009
• First Posted: January 9, 2009
• Study Start: January 1, 2008
• Primary Completion: October 1, 2009
• Study Completion: October 1, 2009
• Last Updated: December 29, 2009

Record last verified: 2009-12

Locations

CA (1)