Safety and Effectiveness Study for a Needle Guidance System in Lung Biopsies

Confirmation of Clinical Effectiveness and Safety of CT-guided Percutaneous Lung Aspiration and Biopsy Performed With the Aid of the ActiSightTM Needle Guidance System

This study is designed to provide clinical data regarding safety and clinical effectiveness of the ActiSight Needle Guidance System in assisting radiologically guided percutaneous needle biopsy or aspiration of pulmonary lesions, which is a common procedure.

Study Overview

• Status: Completed
• Conditions: Lung Diseases
• Intervention / Treatment: Device: ActiSight Needle Guidance System

Detailed Description

This will be a prospective, single-arm study. At least three centers in Canada will participate in the study and at least 4 different experienced staff radiologists will perform the procedures for the study.

A total of forty eight (48) consecutive subjects meeting the eligibility criteria, scheduled for clinically indicated CT guided lung biopsy or aspiration procedure at the participating centers will be invited to enroll in the study. To ensure diversity in the study population, consecutive patients will be enrolled in the following groups until these groups are fully enrolled:

Lesion size ≥1.0 cm and ≤ 1.5 cm: 10 patients; Lesion size >1.5 and ≤ 3.0 cm: 19 patients; Lesion size >3.0 cm: 19 patients.

A maximum of 24 patients will be enrolled at each center.

Informed consent will be signed prior to the procedure. Subject data collection on the day of the procedure will include demographics, relevant medical history and vital signs. Enrolled subjects will undergo CT guided percutaneous lung aspiration and/or biopsy as clinically indicated by a qualified physician, utilizing the ActiSight Needle Guidance System. Subjects will be followed-up as outlined below to assess adverse events related to the procedure. A subject's enrollment in the study will be completed after the follow-up visit or after resolution of any procedure related adverse event.

A procedure difficulty classification is defined for this study, based on existing literature. Difficulty levels for all procedures will be recorded and included in the final report.

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Phase 4

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M4N 3M5
      • Sunnybrook Health Sciences Centre
    • Toronto, Ontario, Canada, M5G1Z6
      • University Health Network, Toronto General Hospital
  • Quebec
    • Montreal, Quebec, Canada, H3A1A1
      • McGill University Health Center, Royal Victoria Hospital, Montreal General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 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 CT guided percutaneous lung aspiration/biopsy;
• Written informed consent to participate in the study;
• Ability to comply with the requirements of the study procedures;
• Verified home address and phone number to facilitate study follow-up.

Exclusion Criteria:

• Significant coagulopathy that cannot be adequately corrected;
• 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;
• Mental impairment that may preclude completion of the study procedure;
• Pregnant or nursing female subjects.

Study Plan

How is the study designed?

Design Details

• 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: Needle Guidance; Lung biopsies performed with the needle guidance system.	Device: ActiSight Needle Guidance System; Three different groups of patients defined per lesion size; Other Names: CT-Guide Needle Guidance System

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients with successful targeting accuracy as defined by the frequency of placing the needle at a location suitable for obtaining tissue sample from the target lesion.	Needle location suitable for obtaining tissue sample will be determined by a physician reviewing the CT images. All 48 subjects undergoing aspiration or biopsy procedures with the CT met the primary efficacy endpoint of placement of the procedure needle at a location suitable for obtaining a tissue sample from the target lesion as determined by the investigator (100%; 95% CI, 93-100%).	30 to 60 minutes after starting the biopsy procedure

Secondary Outcome Measures

Outcome Measure	Time Frame
Total CT-Guided procedure time Patient radiation exposure during the procedure Number of CT scans during the procedure	30 to 60 minutes

Collaborators and Investigators

• Sponsor: ActiViews Ltd.
• Investigators: Principal Investigator: Paul Narinder, MD, University Health Network, Toronto

Study record dates

Study Major Dates

• Study Start: August 1, 2010
• Primary Completion (Actual): February 1, 2011
• Study Completion (Actual): March 1, 2011

Study Registration Dates

• First Submitted: August 13, 2010
• First Submitted That Met QC Criteria: August 16, 2010
• First Posted (Estimate): August 17, 2010

Study Record Updates

• Last Update Posted (Estimate): December 21, 2012
• Last Update Submitted That Met QC Criteria: December 20, 2012
• Last Verified: March 1, 2011

More Information

Terms related to this study

• Keywords: Lung nodule; Lung lesion
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases
• Other Study ID Numbers: ACST-2010-1