Intraoperative, Percutaneous Localization of Peripheral Pulmonary Nodules for Resection: a Prospective, Open-Label, Multi-Center Registry Study of Thoracic Surgery Outcomes.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Veran Medical Technologies
- Enrollment
- 70
- Locations
- 5
- Primary Endpoint
- Rate of successful percutaneous localization and removal of PPN.
Study Overview
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 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 Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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 Criteria
- •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).
Outcomes
Primary Outcomes
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.
Safety of the localization procedure.
Time Frame: Duration of procedure.
Safety data, including instances of adverse events and device deficiencies, will be collected.
Secondary Outcomes
- Weight of excised tissue and margin.(Duration of procedure.)
- Type of surgical resection performed and the resection technique used.(Duration of procedure.)
- Localization method and technique.(Duration of procedure.)
- Intraoperative percutaneous localization time and duration of total surgical procedure.(Duration of procedure.)
- Nodule characteristics, including location in the lobe, distance from pleura, distance from surface of skin to target, morphological appearance, solid vs. ground glass etc.(Duration of procedure.)