Status:
COMPLETED
Percutaneous Localization: Open-label Registry of Thoracic Surgery
Lead Sponsor:
Veran Medical Technologies
Conditions:
Lung Lesion(s) Requiring Evaluation
Pulmonary Metastasis
Eligibility:
All Genders
18+ years
Brief 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 aim...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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).
Key Trial Info
Start Date :
October 10 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 9 2023
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT04066699
Start Date
October 10 2019
End Date
February 9 2023
Last Update
May 17 2024
Active Locations (5)
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1
Kaiser Permanente
Lone Tree, Colorado, United States, 80124
2
Northern Light Eastern Maine Medical Center
Bangor, Maine, United States, 04401
3
Vassar Brothers Medical Center
Poughkeepsie, New York, United States, 12601
4
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27599