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

NCT01183182 | Completed Phase 4

• 1 other identifier: ACST-2010-1
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Lung Diseases

Keywords

Lung nodule; Lung lesion

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Total CT-Guided procedure time Patient radiation exposure during the procedure Number of CT scans during the procedure

  30 to 60 minutes

Study Arms (1)

Needle Guidance

EXPERIMENTAL

Lung biopsies performed with the needle guidance system.

Device: ActiSight Needle Guidance System

Interventions

ActiSight Needle Guidance System DEVICE

Three different groups of patients defined per lesion size

Also known as: CT-Guide Needle Guidance System

Needle Guidance

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 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• ActiViews Ltd.: lead

Study Sites (3)

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

University Health Network, Toronto General Hospital

Toronto, Ontario, M5G1Z6, Canada

Location

McGill University Health Center, Royal Victoria Hospital, Montreal General Hospital

Montreal, Quebec, H3A1A1, Canada

Location

MeSH Terms

Conditions

Lung Diseases

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Study Officials

• Paul Narinder, MD

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2010
• First Posted: August 17, 2010
• Study Start: August 1, 2010
• Primary Completion: February 1, 2011
• Study Completion: March 1, 2011
• Last Updated: December 21, 2012

Record last verified: 2011-03

Locations

CA (3)