NCT04702165
Completed
Phase 1
Image - Navigated Resection of Lung Nodules
ConditionsLung Diseases
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Lung Diseases
- Sponsor
- Navigation Sciences, Inc.
- Enrollment
- 25
- Locations
- 1
- Primary Endpoint
- 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).
- Status
- Completed
- Last Updated
- 9 months ago
Overview
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.
Investigators
Eligibility 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
- •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
Outcomes
Primary Outcomes
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).
Time Frame: 1 day
device feasibility
Secondary Outcomes
- demonstrate safe surgical remove of lung nodule(30 day)
- time required for device placement(1 day)
- whether coefficient is needed(1 day)
Study Sites (1)
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