NCT04066699

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.

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 70 (actual)
• Sponsor: Veran Medical Technologies · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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.

Conditions

• Lung Lesion(s) Requiring Evaluation
• Pulmonary Metastasis
• Pulmonary Nodule, Solitary
• Peripheral Lung Lesions

Interventions

Type	Name	Description
PROCEDURE	Percutaneous localization of suspicious lung lesion(s) using electromagnetic navigation and tools.	Transthoracic localization of suspicious lung lesion(s) in preparation for subsequent resection.

Timeline

• Start date: 2019-10-10
• Primary completion: 2023-01-05
• Completion: 2023-02-09
• First posted: 2019-08-26
• Last updated: 2024-05-17

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated device study