Image - Navigated Resection of Lung Nodules
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1/Phase 2 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: VATS resection with J-bar 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 |
Device: lung resection with Lung Resection Marker Locator Kit
Nodules eligible for surgical resection using the Lung Resection Marker Locator Kit
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Males or females aged 21 years or older as it is extremely rare for younger people to be at risk for lung cancers.
-
Be deemed candidates for the lung resection surgery, which will be determined by their treating Thoracic Surgeon (also a physician investigator)
-
Have lesions that are nodules/GGO or other abnormal opacity that can be accurately measured in at least one dimension using conventional techniques
-
Seen at BWH Thoracic Surgery outpatient clinics or as inpatient (Note: Subjects will be formally consented to the study at BWH only)
Exclusion Criteria:
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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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Brigham and Women's Hospital | Boston | Massachusetts | United States | 02115 |
Sponsors and Collaborators
- Navigation Sciences, Inc.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2020P002692