Percutaneous Localization: Open-label Registry of Thoracic Surgery (NCT04066699) | Clinical Trial Compass
CompletedNot Applicable
Percutaneous Localization: Open-label Registry of Thoracic Surgery
United States70 participantsStarted 2019-10-10
Plain-language summary
The objectives of this study are to evaluate intraoperative percutaneous lung lesion marking assisted by electromagnetic guided percutaneous navigation and related tools.
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:
* Subject's physician and/or thoracic surgeon have deemed/has deemed that the surgical removal of the PPN is appropriate.
* A clinical decision has been made to use the SPiN Thoracic Navigation System™.
* Subject is at least 18 years of age at time of study entry.
* Subject is able to read, understand, and voluntarily sign the IRB-approved informed consent document prior to the performance of any study-specific procedures. IRB- approved translation may be used if indicated. Reasonable accommodation of visually impaired subjects will be allowed.
* Subject is able to tolerate general anesthesia.
* Subject has a target nodule between 0.4 cm and 3.2 cm in greatest dimension;
* The target nodule is in a location that is accessible for percutaneous localization in the judgement of the surgeon.
Exclusion Criteria:
* Subjects with any other concomitant treatment or medical condition that, in the opinion of the clinician, would render peripheral nodule resection more hazardous than beneficial.
* Subject is pregnant.
* Pulmonary nodule is greater than 3.2 cm.
* Subjects with significant coagulopathy having INR \> 2.0 or PTT \> 2x normal.
* Subject is unable to tolerate general anesthesia.
* Obese subject, impacting percutaneous access (BMI \> 50).
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
1
Rate of successful percutaneous localization and removal of PPN.