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

Sponsor
Veran Medical Technologies (Industry)
Overall Status
Completed
CT.gov ID
NCT03338049
Collaborator
(none)
150
Enrollment
9
Locations
1
Arm
21.5
Actual Duration (Months)
16.7
Patients Per Site
0.8
Patients Per Site Per Month

Study Details

Study Description

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
  • Device: Veran System
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
150 participants
Allocation:
N/A
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 :
Feb 14, 2018
Actual Primary Completion Date :
Oct 29, 2019
Actual Study Completion Date :
Dec 1, 2019

Arms and Interventions

Arm Intervention/Treatment
Other: 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 Names:
  • Veran SPiN Thoracic Navigation System SPiNPerc Kit

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Diagnostic Yield [Up to one year post index procedure]

      Diagnostic yield associated with either EMN-bronchoscopy or EMN-TTNA

    Secondary Outcome Measures

    1. Serious Adverse Events [30 days post index procedure]

      All device and/or procedure related serious adverse events

    2. Adverse Events [30 days post index procedure]

      Rate of all device and procedure related events

    3. Rate of procedure cancellation [On procedure day]

      Impact of same day CT scan on rate of procedure cancellations due decrease in nodule size

    4. Procedural Factors [Intra-procedure]

      Number of instrument passes, type of instrument, site of biopsy

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    21 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Banner University Medical Center - Phoenix Phoenix Arizona United States 85006
    2 Grady Memorial Hospital Atlanta Georgia United States 30303
    3 Johns Hopkins Hospital Baltimore Maryland United States 21287
    4 Washington University Medical Center Saint Louis Missouri United States 63110
    5 University of North Carolina Medical Center Chapel Hill North Carolina United States 27514
    6 Duke University Hospital Durham North Carolina United States 27710
    7 University of Pittsburgh Medical Center Pittsburgh Pennsylvania United States 15213
    8 Medical University of South Carolina Medical Center Charleston South Carolina United States 29425
    9 Swedish Medical Center Seattle Washington United States 98122

    Sponsors and Collaborators

    • Veran Medical Technologies

    Investigators

    • Principal Investigator: Lonny Yarmus, DO, Johns Hopkins University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Veran Medical Technologies
    ClinicalTrials.gov Identifier:
    NCT03338049
    Other Study ID Numbers:
    • VMT AIO 2017
    First Posted:
    Nov 9, 2017
    Last Update Posted:
    May 19, 2020
    Last Verified:
    May 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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.:
    No
    Additional relevant MeSH terms:
    Multiple Pulmonary Nodules

    Study Results

    No Results Posted as of May 19, 2020