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| Name | Class |
|---|---|
| Institute for Quality Resource Management | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients recommended for a lung biopsy. | Experimental | Patients with a positive diagnosis of a peripheral, less than 3.0 centimeter lung lesion, recommended for bronchoscopic biopsy are eligible to be consented into the study. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lung biopsy using Always On EM Tip Tracked Device | Procedure | Patients screened by CT to have a subsegmental, less than 3.0 centimeter lung lesion will be assigned to outpatient bronchoscopy. The patient will have a chest CT with the Always on Patient vPad. Access to the lesion will be achieved using Electromagnetic Tip Tracked devices. Once accessed the operator will use the Electromagnetic Tip Tracked devices or standard devices to obtain a biopsy sample to then be to pathology for diagnosis and reporting. Once completed the patient will be moved to recovery and discharged. If the biopsy is negative the patient will be advised by the pulmonologist about other interventions, watchful waiting, or no further treatment. If the biopsy is positive, the patient will be referred to their physician for further treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Momen Wahidi, MD, MBA | Duke University | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12527571 | Background | Schreiber G, McCrory DC. Performance characteristics of different modalities for diagnosis of suspected lung cancer: summary of published evidence. Chest. 2003 Jan;123(1 Suppl):115S-128S. doi: 10.1378/chest.123.1_suppl.115s. | |
| 10492275 | Background | Reichenberger F, Weber J, Tamm M, Bolliger CT, Dalquen P, Perruchoud AP, Soler M. The value of transbronchial needle aspiration in the diagnosis of peripheral pulmonary lesions. Chest. 1999 Sep;116(3):704-8. doi: 10.1378/chest.116.3.704. |
| Label | URL |
|---|---|
| Reduced Lung-Cancer Mortality with Low-Dose CT Screening | View source |
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| ID | Term |
|---|---|
| D003074 | Solitary Pulmonary Nodule |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| 12527568 | Background | Tan BB, Flaherty KR, Kazerooni EA, Iannettoni MD; American College of Chest Physicians. The solitary pulmonary nodule. Chest. 2003 Jan;123(1 Suppl):89S-96S. doi: 10.1378/chest.123.1_suppl.89s. |
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| 17406670 | Background | Landi S, Cenni MC, Maffei L, Berardi N. Environmental enrichment effects on development of retinal ganglion cell dendritic stratification require retinal BDNF. PLoS One. 2007 Apr 4;2(4):e346. doi: 10.1371/journal.pone.0000346. |
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| 16873767 | Background | Gildea TR, Mazzone PJ, Karnak D, Meziane M, Mehta AC. Electromagnetic navigation diagnostic bronchoscopy: a prospective study. Am J Respir Crit Care Med. 2006 Nov 1;174(9):982-9. doi: 10.1164/rccm.200603-344OC. Epub 2006 Jul 27. |
| 18836886 | Background | Lamprecht B, Porsch P, Pirich C, Studnicka M. Electromagnetic navigation bronchoscopy in combination with PET-CT and rapid on-site cytopathologic examination for diagnosis of peripheral lung lesions. Lung. 2009 Jan-Feb;187(1):55-9. doi: 10.1007/s00408-008-9120-8. Epub 2008 Oct 5. |
| 16608948 | Background | Schwarz Y, Greif J, Becker HD, Ernst A, Mehta A. Real-time electromagnetic navigation bronchoscopy to peripheral lung lesions using overlaid CT images: the first human study. Chest. 2006 Apr;129(4):988-94. doi: 10.1378/chest.129.4.988. |
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