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All in One Study: A Prospective Trial of Electromagnetic Navigation for Biopsy of Pulmonary Nodules (AIO)

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ClinicalTrials.gov Identifier: NCT03338049
Recruitment Status : Recruiting
First Posted : November 9, 2017
Last Update Posted : March 26, 2018
Sponsor:
Information provided by (Responsible Party):
Veran Medical Technologies

Brief Summary:
This is a multi-center, non-randomized, single-arm, prospective trial to evaluate a staged sampling methodology designed to maximize the diagnostic yield of lung biopsy in a single procedure setting.

Condition or disease Intervention/treatment Phase
Lung Cancer Device: Veran System Not Applicable

Detailed Description:
The objectives of this study are to evaluate diagnostic yield following biopsy of peripheral pulmonary nodules as identified on chest computed tomography (CT) utilizing (1) Electromagnetic navigation (EMN) bronchoscopy, and/or (2) EMN-transthoracic needle aspiration (TTNA). Overall diagnostic yield will be evaluated to assess the combination of these approaches.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Multicenter, Prospective Trial of ElectromagnetIc Bronchoscopic and Electromagnetic Transthoracic Navigational Approaches for the Biopsy of Peripheral Pulmonary Nodules
Actual Study Start Date : February 14, 2018
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : January 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy
U.S. FDA Resources

Arm Intervention/treatment
Veran System
Staged biopsy sampling methodology. If lymph node staging is negative, EMN-bronchoscopy will be performed. If EMN-bronchoscopy is negative, EMN-TTNA will be performed
Device: Veran System
Electromagnetic navigation bronchoscopy and electromagnetic navigation transthoracic needle aspiration
Other Name: Veran SPiN Thoracic Navigation System SPiNPerc Kit



Primary Outcome Measures :
  1. Diagnostic Yield [ Time Frame: Up to one year post index procedure ]
    Diagnostic yield associated with either EMN-bronchoscopy or EMN-TTNA


Secondary Outcome Measures :
  1. Serious Adverse Events [ Time Frame: 30 days post index procedure ]
    All device and/or procedure related serious adverse events

  2. Adverse Events [ Time Frame: 30 days post index procedure ]
    Rate of all device and procedure related events

  3. Rate of procedure cancellation [ Time Frame: On procedure day ]
    Impact of same day CT scan on rate of procedure cancellations due decrease in nodule size

  4. Procedural Factors [ Time Frame: Intra-procedure ]
    Number of instrument passes, type of instrument, site of biopsy



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Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • The patient is ≥21 years old,
  • The patient has a lung nodule identified on chest CT and is a candidate for elective EMN bronchoscopic evaluation as determined by the treating pulmonologist,
  • The size of the target nodule, as measured at its greatest diameter, is between 1-3cm,
  • Staging at the time of enrollment indicates NO/N1 (does not involve lymph nodes or includes involvement in nodes within ipsilateral hilum),
  • The patient has an intermediate risk of malignancy (5-65% per the Mayo Model) and is in need of diagnosis for alternative treatment, OR The patient has a high probability of cancer (>65%) and will be referred for surgical evaluation or stereotactic body radiation therapy (SBRT). Note: If the patient refuses surgery or if the surgeon requests a definitive diagnosis prior to surgery the patient will have the option to be included in this study,
  • The patient has a lack of bleeding disorders, and
  • The patient is willing and able to provide informed consent.

Exclusion Criteria:

  • The patient is pregnant as confirmed by urine or serum pregnancy testing,
  • The patients has a body mass index (BMI) >40,
  • There is a predetermined plan to pursue stereotactic body radiation therapy (SBRT) in the event of a nondiagnostic study procedure in patients with a nodule within SPiNPerc range (i.e. The patient would not go on for a CT guided TTNA), OR There is a predetermined plan to pursue stereotactic body radiation therapy (SBRT) in the event of a nondiagnostic study procedure in patients where the target nodule is within a region considered to be not accessible to a percutaneous approach as determined by the radiology core lab and thus would prevent a confirmatory tissue diagnosis before SBRT.

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): NCT03338049


Locations
United States, Georgia
Grady Memorial Hospital Recruiting
Atlanta, Georgia, United States, 30303
Contact: Chad Anderson    404-616-7349    canderson@gmh.edu   
United States, Maryland
Johns Hopkins Hospital Recruiting
Baltimore, Maryland, United States, 21287
Contact: Jennifer Los    410-955-5288    Jlos1@jhmi.edu   
United States, Missouri
Washington University Medical Center Not yet recruiting
Saint Louis, Missouri, United States, 63110
Contact: Amanda Kesjaral       akesjaral@email.wustl.edu   
United States, North Carolina
University of North Carolina Medical Center Recruiting
Chapel Hill, North Carolina, United States, 27514
Contact: Ashley Delgado    919-445-0367    ashley_delgado@med.unc.edu   
Duke University Hospital Not yet recruiting
Durham, North Carolina, United States, 27710
Contact: Kathleen Coles    919-668-3812    Kathleen.coles@duke.edu   
United States, Pennsylvania
University of Pittsburgh Medical Center Not yet recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Christina Ledezma, PhD    412-864-3368    ledezmacm@upmc.edu   
United States, South Carolina
Medical University of South Carolina Medical Center Recruiting
Charleston, South Carolina, United States, 29425
Contact: Mike Balassone    843-792-6696    Balassom@musc.edu   
United States, Washington
Swedish Medical Center Not yet recruiting
Seattle, Washington, United States, 98122
Contact: Andrew Smith    206-386-2450    andrew.smith@swedish.org   
Sponsors and Collaborators
Veran Medical Technologies
Investigators
Principal Investigator: Lonny Yarmus, DO Johns Hopkins University

Responsible Party: Veran Medical Technologies
ClinicalTrials.gov Identifier: NCT03338049     History of Changes
Other Study ID Numbers: VMT AIO 2017
First Posted: November 9, 2017    Key Record Dates
Last Update Posted: March 26, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
Multiple Pulmonary Nodules
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases