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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
ActiViews Ltd.
ClinicalTrials.gov Identifier:
NCT01183182
First received: August 13, 2010
Last updated: December 20, 2012
Last verified: March 2011
  Purpose

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.


Condition Intervention Phase
Lung Diseases
Device: ActiSight Needle Guidance System
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
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

Further study details as provided by ActiViews Ltd.:

Primary Outcome Measures:
  • 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. [ Time Frame: 30 to 60 minutes after starting the biopsy procedure ] [ Designated as safety issue: Yes ]

    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%).



Secondary Outcome Measures:
  • Total CT-Guided procedure time Patient radiation exposure during the procedure Number of CT scans during the procedure [ Time Frame: 30 to 60 minutes ] [ Designated as safety issue: Yes ]

Enrollment: 48
Study Start Date: August 2010
Study Completion Date: March 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: CT-Guide 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01183182

Locations
Canada, Ontario
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5
University Health Network, Toronto General Hospital
Toronto, Ontario, Canada, M5G1Z6
Canada, Quebec
McGill University Health Center, Royal Victoria Hospital, Montreal General Hospital
Montreal, Quebec, Canada, H3A1A1
Sponsors and Collaborators
ActiViews Ltd.
Investigators
Principal Investigator: Paul Narinder, MD University Health Network, Toronto
  More Information

No publications provided

Responsible Party: ActiViews Ltd.
ClinicalTrials.gov Identifier: NCT01183182     History of Changes
Other Study ID Numbers: ACST-2010-1
Study First Received: August 13, 2010
Last Updated: December 20, 2012
Health Authority: Canada: Ethics Review Committee

Keywords provided by ActiViews Ltd.:
Lung nodule
Lung lesion

Additional relevant MeSH terms:
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on September 18, 2014