Pulmonary Coin Lesion Clinical Trial
Official title:
A Pilot Prospective Study Evaluating the SPiN Drive(TM)Electromagnetic Tip Tracked Devices Used in Diagnostic Bronchoscopy
The objective of the prospective, multi-center study is to evaluate the ease of use and effectiveness of the SPiN Drive Electromagnetic (EM) Tip Tracked Steerable Devices as a method of sampling subsegmental, less than 3.0 cm, lung lesions through the airway, and beyond the bronchus. Measures of diagnostic yield will be compared to the diagnostic yield of similar published historical controls using conventional 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
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01730365 -
Optical Detection of Malignancy During Percutaneous Interventions
|
N/A |