A Pilot Prospective Study Evaluating the SPiN Drive(TM)Electromagnetic Tip Tracked Devices Used in Diagnostic Bronchoscopy
Always On EM Tip Tracked Steerable catheters and biopsy devices used with the Veran Medical
Technologies system are Food and Durg Administration 510K approved for use in diagnostic
pulmonary procedures to locate and sample subsegmental peripheral, less than 3.0 centimeter
lung lesions or solitary pulmonary nodules(SPN).
Up to 20 subjects with radiographically confirmed peripheral lung lesions will be asked to
participate in the study and proceed with informed consent. An interim analysis of the data
will be conducted to determine the need to include an additional 10 patients to achieve
statistically significant results at the ninety five percent confidence interval.
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Diagnostic
Diagnostic yield of a subsegmental pulmonary lesion of less than 3.0 cm.
Biopsy samples will be sent to the lab for analysis of the presence, absence, or identification of an occult particulate taken from the patient's lung. Patients with a negative biopsy result will be followed if recommended for another intervention and if recommended to watchful waiting. Follow up outcomes will be included in the outcome measures.
Within 1 week
Momen Wahidi, MD, MBA
United States: Institutional Review Board
|St. Elizabeth's Medical Center||Boston, Massachusetts 02135-2997|
|Duke University Medical Center||Durham, North Carolina 27710|
|Barnes Jewish Hospital||St. Louis, Missouri 63110|