CompletedPhase 4

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

Canada48 participantsStarted 2010-08

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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.

Timeframe: 30 to 60 minutes after starting the biopsy procedure

Trial details

NCT IDNCT01183182

SponsorActiViews Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2011-02

View on ClinicalTrials.gov More Lung Diseases trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.