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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

August 13, 2010
December 20, 2012
August 2010
February 2011   (final data collection date for primary outcome measure)
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%).

o Targeting accuracy as defined by the ability to place the needle at a location suitable for obtaining tissue sample from the target lesion, as determined by a physician reviewing the CT images. [ Time Frame: 30 to 60 minutes ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01183182 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
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.

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.

Interventional
Phase 4
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Lung Diseases
Device: ActiSight Needle Guidance System
Three different groups of patients defined per lesion size
Other Name: CT-Guide Needle Guidance System
Experimental: Needle Guidance
Lung biopsies performed with the needle guidance system.
Intervention: Device: ActiSight Needle Guidance System
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
48
March 2011
February 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT01183182
ACST-2010-1
No
ActiViews Ltd.
ActiViews Ltd.
Not Provided
Principal Investigator: Paul Narinder, MD University Health Network, Toronto
ActiViews Ltd.
March 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP