Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
25 participants
INTERVENTIONAL
2021-06-03
2022-06-16
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DEVICE_FEASIBILITY
NONE
Study Groups
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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
lung resection with Lung Resection Marker Locator Kit
Nodules eligible for surgical resection using the Lung Resection Marker Locator Kit
Interventions
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lung resection with Lung Resection Marker Locator Kit
Nodules eligible for surgical resection using the Lung Resection Marker Locator Kit
Eligibility Criteria
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Inclusion Criteria
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
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
\-
21 Years
ALL
No
Sponsors
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Navigation Sciences, Inc.
INDUSTRY
Responsible Party
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Locations
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Brigham and Women's Hospital
Boston, Massachusetts, United States
Countries
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Other Identifiers
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2020P002692
Identifier Type: -
Identifier Source: org_study_id
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