Percutaneous Localization: Open-label Registry of Thoracic Surgery (PLOTS)
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|ClinicalTrials.gov Identifier: NCT04066699|
Recruitment Status : Unknown
Verified March 2021 by Veran Medical Technologies.
Recruitment status was: Recruiting
First Posted : August 26, 2019
Last Update Posted : March 30, 2021
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|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 2022|
|Estimated Study Completion Date :||April 2022|
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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
|Sampling Method:||Non-Probability Sample|
- 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.
- 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).
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: Nathan Hunt||314-659-8500||PLOTS@veranmedical.com|
|United States, Colorado|
|Lone Tree, Colorado, United States, 80124|
|Contact: Lanny Dunham, 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, North Carolina|
|University of North Carolina at Chapel Hill||Recruiting|
|Chapel Hill, North Carolina, United States, 27599|
|Contact: Jason Long, MD|
|United States, Texas|
|Houston Methodist Hospital||Recruiting|
|Houston, Texas, United States, 77030|
|Contact: Min Kim, MD|
|Principal Investigator:||Faiz Bhora, MD||Vassar Brothers Medical Center|
|Responsible Party:||Veran Medical Technologies|
|Other Study ID Numbers:||
|First Posted:||August 26, 2019 Key Record Dates|
|Last Update Posted:||March 30, 2021|
|Last Verified:||March 2021|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||Yes|
|Product Manufactured in and Exported from the U.S.:||Yes|
Surgical Lung Resection
Peripheral Pulmonary Nodule(s)
Multiple Pulmonary Nodules
Solitary Pulmonary Nodule
Respiratory Tract Neoplasms
Neoplasms by Site
Respiratory Tract Diseases