Back to resultsImage - Navigated Resection of Lung Nodules
Primary Purpose
Lung Diseases
Status
Active
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
lung resection with Lung Resection Marker Locator Kit
Sponsored by
About this trial
This is an interventional device feasibility trial for Lung Diseases focused on measuring lung nodule, lung cancer, lung mass
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
-
Sites / Locations
- Brigham and Women's Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
VATS resection with J-bar
Arm Description
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
Outcomes
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).
device feasibility
Secondary Outcome Measures
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
time required for device placement
3. To determine the length of time needed for the placement of the device and record measurements.
demonstrate safe surgical remove of lung nodule
no increased surgical morbidity from the operation
Full Information
NCT ID
NCT04702165
First Posted
December 23, 2020
Last Updated
September 27, 2022
Sponsor
Navigation Sciences, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT04702165
Brief Title
Image - Navigated Resection of Lung Nodules
Official Title
Image - Navigated Resection of Lung Nodules
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 3, 2021 (Actual)
Primary Completion Date
April 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Navigation Sciences, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Diseases
Keywords
lung nodule, lung cancer, lung mass
7. Study Design
Primary Purpose
Device Feasibility
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
VATS resection with J-bar
Arm Type
Experimental
Arm Description
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
Intervention Type
Device
Intervention Name(s)
lung resection with Lung Resection Marker Locator Kit
Intervention Description
Nodules eligible for surgical resection using the Lung Resection Marker Locator Kit
Primary Outcome Measure Information:
Title
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).
Description
device feasibility
Time Frame
1 day
Secondary Outcome Measure Information:
Title
whether coefficient is needed
Description
To determine whether a coefficient needs to be defined to harmonize the distance measured with the device to that found by pathologists
Time Frame
1 day
Title
time required for device placement
Description
3. To determine the length of time needed for the placement of the device and record measurements.
Time Frame
1 day
Title
demonstrate safe surgical remove of lung nodule
Description
no increased surgical morbidity from the operation
Time Frame
30 day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
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
-
Facility Information:
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Image - Navigated Resection of Lung Nodules
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