All in One Study: A Prospective Trial of Electromagnetic Navigation for Biopsy of 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.
Checked against the public recordLast updated May 19, 2020 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Diagnostic
- Study type
- Interventional
- Phase
- Not applicable
- Sponsor
- Veran Medical Technologies
- Interventions being studied
- Device: Veran System
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
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.
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Banner University Medical Center - PhoenixPhoenix, Arizona
- Grady Memorial HospitalAtlanta, Georgia
- Johns Hopkins HospitalBaltimore, Maryland
- Washington University Medical CenterSt Louis, Missouri
- University of North Carolina Medical CenterChapel Hill, North Carolina
- Duke University HospitalDurham, North Carolina
- University of Pittsburgh Medical CenterPittsburgh, Pennsylvania
- Medical University of South Carolina Medical CenterCharleston, South Carolina
- Swedish Medical CenterSeattle, Washington
Source and freshness
Processed from ClinicalTrials.gov. Last public update: May 19, 2020. Always confirm current availability with the study team.