Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
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 : December 4, 2019
Sponsor:
Information provided by (Responsible Party):
Veran Medical Technologies

Brief Summary:
The objectives of this study are to evaluate intraoperative percutaneous lung lesion marking assisted by electromagnetic guided percutaneous navigation and related tools.

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.

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.

Layout table for study information
Study Type : Observational [Patient Registry]
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Group/Cohort Intervention/treatment
Localization
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.
Other Names:
  • SPiN Thoracic Navigation System™
  • Veran System




Primary Outcome Measures :
  1. 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.

  2. Collect safety data for localization procedure. [ Time Frame: Duration of procedure. ]

Secondary Outcome Measures :
  1. 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..

  2. 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.

  3. 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. ]
  4. Record weight of excised tissue and margin. [ Time Frame: Duration of procedure. ]
  5. 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.



Information from the National Library of Medicine

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.


Layout table for eligibility information
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
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.
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).

Information from the National Library of Medicine

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


Contacts
Layout table for location contacts
Contact: Susan Shelby, PhD 314-659-8500 PLOTS@veranmedical.com

Locations
Layout table for location information
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         
Sponsors and Collaborators
Veran Medical Technologies
Investigators
Layout table for investigator information
Principal Investigator: Faiz Bhora, MD Vassar Brothers Medical Center
Publications:
Layout table for additonal information
Responsible Party: Veran Medical Technologies
ClinicalTrials.gov Identifier: NCT04066699    
Other Study ID Numbers: VMT-01-003
First Posted: August 26, 2019    Key Record Dates
Last Update Posted: December 4, 2019
Last Verified: December 2019

Layout table for additional information
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
Keywords provided by Veran Medical Technologies:
Surgical Lung Resection
Percutaneous Localization
Electromagnetic Navigation
Transthoracic Localization
Peripheral Pulmonary Nodule(s)
Additional relevant MeSH terms:
Layout table for MeSH terms
Multiple Pulmonary Nodules
Solitary Pulmonary Nodule
Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases