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

Lung Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01183182
• Other study ID #: ACST-2010-1
• Status: Completed
• Phase: Phase 4
• First received: August 13, 2010
• Last updated: December 20, 2012
• Start date: August 2010
• Est. completion date: March 2011

Study information

• Verified date: March 2011
• Source: ActiViews Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: March 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Lung Diseases

Intervention

Device:
• ActiSight Needle Guidance System
Three different groups of patients defined per lesion size

Locations

Country	Name	City	State
Canada	McGill University Health Center, Royal Victoria Hospital, Montreal General Hospital	Montreal	Quebec
Canada	Sunnybrook Health Sciences Centre	Toronto	Ontario
Canada	University Health Network, Toronto General Hospital	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
ActiViews Ltd.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Total CT-Guided procedure time Patient radiation exposure during the procedure Number of CT scans during the procedure		30 to 60 minutes	Yes