Percutaneous Localization: Open-label Registry of Thoracic Surgery (PLOTS)
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|ClinicalTrials.gov Identifier: NCT04066699|
Recruitment Status : Recruiting
First Posted : August 26, 2019
Last Update Posted : December 4, 2019
|Condition or disease||Intervention/treatment|
|Lung Lesion(s) Requiring Evaluation Pulmonary Metastasis Pulmonary Nodule, Solitary Peripheral Lung Lesions||Procedure: Percutaneous localization of suspicious lung lesion(s) using electromagnetic navigation and 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.
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||100 participants|
|Target Follow-Up Duration:||6 Weeks|
|Official Title:||Intraoperative, Percutaneous Localization of Peripheral Pulmonary Nodules for Resection: a Prospective, Open-Label, Multi-Center Registry Study of Thoracic Surgery Outcomes.|
|Actual Study Start Date :||October 10, 2019|
|Estimated Primary Completion Date :||February 2021|
|Estimated Study Completion Date :||April 2021|
Electromagnetic navigation (EMN) guided percutaneous localization of suspicious lung lesion(s).
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.
- Rate of successful percutaneous localization and removal of PPN. [ Time Frame: Duration of procedure. ]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.
- Collect safety data for localization procedure. [ Time Frame: Duration of procedure. ]
- Report localization method and technique. [ Time Frame: Duration of procedure. ]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..
- Collect data on intraoperative percutaneous localization time and duration of total surgical procedure. [ Time Frame: Duration of procedure. ]The time of the localization procedure will be recorded. The length of the entire surgical procedure will also be recorded.
- Record nodule characteristics, including location in the lobe, distance from pleura, distance from surface of skin to target, morphological appearance, solid vs. ground glass etc. [ Time Frame: Duration of procedure. ]
- Record weight of excised tissue and margin. [ Time Frame: Duration of procedure. ]
- Report type of surgical resection performed and the resection technique used. [ Time Frame: Duration of procedure. ]The surgical resection may include segmentectomy or wedge using the VATS, RATS, or thoracotomy techniques.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04066699
|Contact: Susan Shelby, PhD||314-659-8500||PLOTS@veranmedical.com|
|United States, Colorado|
|Kaiser Permanente||Not yet recruiting|
|Lone Tree, Colorado, United States, 80124|
|Contact: Lanny Dunham, MD|
|United States, District of Columbia|
|MedStar Washington Hospital Center||Not yet recruiting|
|Washington, District of Columbia, United States, 20010|
|Contact: John Lazar, MD|
|United States, Maine|
|Northern Light Eastern Maine Medical Center||Recruiting|
|Bangor, Maine, United States, 04401|
|Contact: Jawad Latif, MD|
|United States, New York|
|Vassar Brothers Medical Center||Recruiting|
|Poughkeepsie, New York, United States, 12601|
|Contact: Faiz Bhora, MD|
|United States, Texas|
|Houston Methodist Hospital||Recruiting|
|Houston, Texas, United States, 77030|
|Contact: Min Kim, MD|
|United States, Wisconsin|
|University of Wisconsin||Not yet recruiting|
|Madison, Wisconsin, United States, 53792|
|Contact: Malcolm DeCamp, MD|
|Principal Investigator:||Faiz Bhora, MD||Vassar Brothers Medical Center|