Lung Diseases
Conditions
Keywords
lung nodule, lung cancer, lung mass
Brief summary
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.
Interventions
DEVICElung resection with Lung Resection Marker Locator Kit
Nodules eligible for surgical resection using the Lung Resection Marker Locator Kit
Sponsors
Navigation Sciences, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Males or females aged 21 years or older as it is extremely rare for younger people to be at risk for lung cancers. 2. Be deemed candidates for the lung resection surgery, which will be determined by their treating Thoracic Surgeon (also a physician investigator) 3. Have lesions that are nodules/GGO or other abnormal opacity that can be accurately measured in at least one dimension using conventional techniques 4. Seen at BWH Thoracic Surgery outpatient clinics or as inpatient (Note: Subjects will be formally consented to the study at BWH only)
Exclusion criteria
1. Female subjects pregnant or breastfeeding 2. Subjects with a pacemaker or equivalent devices (AICD) due to the use of electromagnetic tracking generator. 3. Patients who are not scheduled for lung surgery \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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). | 1 day | device feasibility |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| whether coefficient is needed | 1 day | To determine whether a coefficient needs to be defined to harmonize the distance measured with the device to that found by pathologists |
| time required for device placement | 1 day | 3\. To determine the length of time needed for the placement of the device and record measurements. |
| demonstrate safe surgical remove of lung nodule | 30 day | no increased surgical morbidity from the operation |
Countries
United States
Outcome results
None listed