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Electromagnetic navigation (EMN) guided percutaneous localization of suspicious lung lesion(s).

Transthoracic localization of suspicious lung lesion(s) in preparation for subsequent resection.

Percutaneous localization of suspicious lung lesion(s) using electromagnetic navigation and tools.

Faiz Bhora, MD

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

The Intraoperative, Percutaneous Localization of Peripheral Pulmonary Nodules for Resection: a Prospective, Open-Label, Multi-Center Registry Study of Thoracic Surgery Outcomes (PLOTS) registry is aimed at developing a high quality set of data regarding intraoperative percutaneous localization of peripheral pulmonary nodules (PPNs), and then identifying and promulgating efficient, evidence-based best practices for this technique. The resection procedure itself is standard of care and follows the investigator's standard protocol.

Successful localization of PPNs is a challenge involving multiple factors, beginning with the subjects' health, lung function and also factors specific to the nodule including location within the lung, size, distance from the lung surface, whether solid or ground glass and proximity to a fissure. Hard to see or palpate nodules are currently localized with dye and/or hook wires or fiducials, either endoscopically or percutaneously. Successful, large, prospective studies have not been reported using modern electro-magnetic navigation (EMN)-guided percutaneous intraoperative localization, and different techniques (dye vs. fiducial vs. hook wire etc.) have not been broadly evaluated. It is for these reasons that the different localization techniques used with EMN-guided percutaneous localization will be collected for patients having a suspicious nodule and who undergo percutaneous intra-operative localization and immediate resection.

This registry aims to record the localization techniques used by thoracic surgeons and IP/surgical teams to identify PPNs using the SPiN Thoracic Navigation System™ in the hands of trained physicians. The objectives of this study will be to accomplish the primary and secondary objectives listed below, and to observe localization in a real world context of pulmonary resection.

Percutaneous Localization: Open-label Registry of Thoracic Surgery

Intraoperative, Percutaneous Localization of Peripheral Pulmonary Nodules for Resection: a Prospective, Open-Label, Multi-Center Registry Study of Thoracic Surgery Outcomes.

Successful percutaneous localization of PPN defined as the percentage of subjects in whom the nodule is successfully localized and removed in the first resected specimen.

Safety data, including instances of adverse events and device deficiencies, will be collected.

Details regarding the localization technique will be collected, including the materials used. If dye (methylene blue, ICG etc.) is used the volume will be collected. Other materials include microcoils, hook wires, etc..

The time of the localization procedure will be recorded. The length of the entire surgical procedure will also be recorded.

Details regarding nodule characteristics - solid, semisolid, groundglass; location in relation to anatomical markers and position; size; presence of spiculation - will be collected.

The weight (in grams) of excised tissue will be recorded, as well as the measurement of the included margin.

The surgical resection may include segmentectomy or wedge using the VATS, RATS, or thoracotomy techniques.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Percutaneous Localization: Open-label Registry of Thoracic Surgery	NCT04066699	Lung Lesion(s) ... Pulmonary Metas... Pulmonary Nodul... Peripheral Lung...	Percutaneous lo...	18 Years -	Veran Medical Technologies
Percutaneous Localization: Open-label Registry of Thoracic Surgery	NCT04066699	Lung Lesion(s) ... Pulmonary Metas... Pulmonary Nodul... Peripheral Lung...	Percutaneous lo...	18 Years -	Veran Medical Technologies

Spots Global Cancer Trial Database for lung lesion(s) requiring evaluation