Percutaneous Localization: Open-label Registry of Thoracic Surgery

Completed

Conditions studied: Lung Lesion(s) Requiring Evaluation, Pulmonary Metastasis, Pulmonary Nodule, Solitary, Peripheral Lung Lesions

In brief

The objectives of this study are to evaluate intraoperative percutaneous lung lesion marking assisted by electromagnetic guided percutaneous navigation and related tools.

Key facts

Study ID

NCT04066699

Run by

Veran Medical Technologies

People needed

70

Starts

2019-10-10

Expected to finish

2023-02-09

Last updated by the study team

2024-05-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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).

Where it is running

• Kaiser Permanente — Lone Tree, Colorado, United States
• Northern Light Eastern Maine Medical Center — Bangor, Maine, United States
• Vassar Brothers Medical Center — Poughkeepsie, New York, United States
• University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States
• Houston Methodist Hospital — Houston, Texas, United States

Full record on ClinicalTrials.gov

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