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 range18 Years
SexALL
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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).
What they're measuring
1
Rate of successful percutaneous localization and removal of PPN.