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

May 18, 2020 updated by: Veran Medical Technologies

Multicenter, Prospective Trial of ElectromagnetIc Bronchoscopic and Electromagnetic Transthoracic Navigational Approaches for the Biopsy of Peripheral Pulmonary Nodules

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
150

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85006
        • Banner University Medical Center - Phoenix
    • Georgia
      • Atlanta, Georgia, United States, 30303
        • Grady Memorial Hospital
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Johns Hopkins Hospital
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Washington University Medical Center
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27514
        • University of North Carolina Medical Center
      • Durham, North Carolina, United States, 27710
        • Duke University Hospital
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • University of Pittsburgh Medical Center
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina Medical Center
    • Washington
      • Seattle, Washington, United States, 98122
        • Swedish Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Diagnostic Yield
Time Frame: Up to one year post index procedure
Diagnostic yield associated with either EMN-bronchoscopy or EMN-TTNA
Up to one year post index procedure

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Serious Adverse Events
Time Frame: 30 days post index procedure
All device and/or procedure related serious adverse events
30 days post index procedure
Adverse Events
Time Frame: 30 days post index procedure
Rate of all device and procedure related events
30 days post index procedure
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
On procedure day
Procedural Factors
Time Frame: Intra-procedure
Number of instrument passes, type of instrument, site of biopsy
Intra-procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Veran Medical Technologies

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 14, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 29, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 25, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 6, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 9, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 19, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 18, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • VMT AIO 2017

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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