Safety & Accuracy of the ActiSight Needle Guidance System in Percutaneous Chest Aspiration and Biopsy (ANGS-PCAB)

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 Chest Aspiration And Biopsy

This study is intended to provide clinical data regarding safety and accuracy of the ActiSight™ Needle Guidance System in assisting Chest CT guided biopsies.

Study Overview

• Status: Completed
• Conditions: Biopsy
• Intervention / Treatment: Device: Biopsy needle guidance system (ActiSight™)

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Tel Aviv, Israel, 64239
    • Tel Aviv Sourasky Medical Center

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 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
• INR <1.3
• Written informed consent to participate in the study
• Ability to comply with the requirements of the study procedures

Exclusion Criteria:

• Fibrous tissue or cyst in access path (not including target lesion)
• Hemophilia, thrombocytopenia, coagulopathy, or other elevated risk for bleeding or abnormal clotting
• Central lesion is located in radius of less than 2 cm from lobar blood vessels and the heart.
• The selected needle path has a safety margin of less than 2 cm from major blood vessels and the heart
• Use of ticlopidine or similar antithrombotic medication
• For subjects taking warfarin or other anticoagulant medication, INR >1.3
• Pulmonary hypertension, heart failure, renal failure, or blood dyscrasia
• Subjects who cannot tolerate mild sedation
• Subjects with FEV1 < 800 mL unless approved by principal investigator following consultation with multidisciplinary team

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

  • Platelet count <100,000/mL
  • APTT >39 sec or PT >15 sec
• 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: DIAGNOSTIC
• Allocation: NON_RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Frequency of target reached within a radius of 8 mm from the preplanned targeted point as measured on the final CT scan.	Measure evaluated during entire course of study

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of needle punctures through the skin	Measure evaluated during entire course of study
Number of needle punctures through the pleura	Measure evaluated during entire course of study
Number of CT scans needed	Measure evaluated during entire course of study
Radial distance at target plane at the needle's final position as shown on the ActiSight screen	Measure evaluated during entire course of study
Adverse events following the procedure, including the following:Pneumothorax, Hemoptysis >100 ml, Bleeding, Collapsed lung, Chest drainage, Need for hospitalization	Measure evaluated during entire course of study

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start: December 1, 2008
• Primary Completion (ACTUAL): June 1, 2009
• Study Completion (ACTUAL): June 1, 2009

Study Registration Dates

• First Submitted: December 23, 2008
• First Submitted That Met QC Criteria: December 23, 2008
• First Posted (ESTIMATE): December 24, 2008

Study Record Updates

• Last Update Posted (ESTIMATE): December 30, 2009
• Last Update Submitted That Met QC Criteria: December 29, 2009
• Last Verified: December 1, 2009

More Information

Terms related to this study

• Keywords: Biopsy; Fine needle aspiration
• Other Study ID Numbers: ASNG-LFNA-101-IL (Other Identifier: Protocol #)