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This is an open label study lung nodules that are either cancer or non-cancer and who are eligible for surgical resection. Patients will undergo their surgery with the help of the Lung Resection Marker Locator Kit which will assist the surgeon in both the location and resection of the lung nodule under real-time guidance.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VATS resection with J-bar | Experimental | Each patient with a lung nodule meeting criteria will undergo a lung resection which could be one of three approaches: iVATS with Dyna-CT, VATS, or open. Each approach will use a the experimental device the Lung Resection Marker Locator Kit |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| lung resection with Lung Resection Marker Locator Kit | Device | Nodules eligible for surgical resection using the Lung Resection Marker Locator Kit |
|
| Measure | Description | Time Frame |
|---|---|---|
| To compare the measurements from the J-bar fiducial to the first staple line obtained by the device in vivo to that performed in the frozen section room on the lung specimen obtained (which includes both the J bar and the staple line). | device feasibility | 1 day |
| Measure | Description | Time Frame |
|---|---|---|
| whether coefficient is needed | To determine whether a coefficient needs to be defined to harmonize the distance measured with the device to that found by pathologists | 1 day |
| time required for device placement |
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Inclusion Criteria:
Exclusion Criteria:
Female subjects pregnant or breastfeeding
Subjects with a pacemaker or equivalent devices (AICD) due to the use of electromagnetic tracking generator.
Patients who are not scheduled for lung surgery
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | United States |
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| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D012140 | Respiratory Tract Diseases |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
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3. To determine the length of time needed for the placement of the device and record measurements.
| 1 day |
| demonstrate safe surgical remove of lung nodule | no increased surgical morbidity from the operation | 30 day |
| D009369 | Neoplasms |