We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Percutaneous Localization: Open-label Registry of Thoracic Surgery (PLOTS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04066699
Recruitment Status : Recruiting
First Posted : August 26, 2019
Last Update Posted : March 30, 2021
Sponsor:
Information provided by (Responsible Party):
Veran Medical Technologies

Tracking Information
First Submitted Date August 21, 2019
First Posted Date August 26, 2019
Last Update Posted Date March 30, 2021
Actual Study Start Date October 10, 2019
Estimated Primary Completion Date February 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 21, 2019)
  • 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. ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: August 23, 2019)
  • 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.
Original Secondary Outcome Measures
 (submitted: August 21, 2019)
  • Report localization methods and techniques - dye and materials used, volume of dye (methylene blue, ICG etc.), other materials such as microcoils, hook wires etc. Details regarding these techniques will be collected. [ Time Frame: Duration of procedure. ]
  • 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 (segmentectomy or wedge) and resection technique (VATS, RATS, thoracotomy). [ Time Frame: Duration of procedure. ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Percutaneous Localization: Open-label Registry of Thoracic Surgery
Official Title Intraoperative, Percutaneous Localization of Peripheral Pulmonary Nodules for Resection: a Prospective, Open-Label, Multi-Center Registry Study of Thoracic Surgery Outcomes.
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 Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 6 Weeks
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population The target subject population includes adult subjects (18 years - 85 years), with small, suspicious lung lesions. Patients with small, indeterminate PPNs that, in the judgment of the thoracic surgeon, based on surgical risk and risk of malignancy, warrant lung resection via a percutaneous localization approach. Data will be collected from study subjects having a PPN between 0.4 cm and 3.2 cm in greatest dimension, that are accessible to percutaneous localization, who consent to and undergo intraoperative dye/wire localization procedure followed by surgical lung resection.
Condition
  • Lung Lesion(s) Requiring Evaluation
  • Pulmonary Metastasis
  • Pulmonary Nodule, Solitary
  • Peripheral Lung Lesions
Intervention 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.
Other Names:
  • SPiN Thoracic Navigation System™
  • Veran System
Study Groups/Cohorts Localization
Electromagnetic navigation (EMN) guided percutaneous localization of suspicious lung lesion(s).
Intervention: Procedure: Percutaneous localization of suspicious lung lesion(s) using electromagnetic navigation and tools.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: August 21, 2019)
100
Original Estimated Enrollment Same as current
Estimated Study Completion Date April 2022
Estimated Primary Completion Date February 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria

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).
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Nathan Hunt 314-659-8500 PLOTS@veranmedical.com
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT04066699
Other Study ID Numbers VMT-01-003
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement Not Provided
Current Responsible Party Veran Medical Technologies
Original Responsible Party Same as current
Current Study Sponsor Veran Medical Technologies
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators
Principal Investigator: Faiz Bhora, MD Vassar Brothers Medical Center
PRS Account Veran Medical Technologies
Verification Date March 2021