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Image - Navigated Resection of Lung Nodules

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ClinicalTrials.gov Identifier: NCT04702165
Recruitment Status : Recruiting
First Posted : January 8, 2021
Last Update Posted : April 8, 2022
Sponsor:
Information provided by (Responsible Party):
Navigation Sciences, Inc.

Study Description
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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
Lung Diseases Device: lung resection with Lung Resection Marker Locator Kit Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Official Title: Image - Navigated Resection of Lung Nodules
Actual Study Start Date : June 3, 2021
Estimated Primary Completion Date : September 2022
Estimated Study Completion Date : January 2023
Arms and Interventions
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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
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Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. whether coefficient is needed [ Time Frame: 1 day ]
    To determine whether a coefficient needs to be defined to harmonize the distance measured with the device to that found by pathologists

  2. time required for device placement [ Time Frame: 1 day ]
    3. To determine the length of time needed for the placement of the device and record measurements.

  3. demonstrate safe surgical remove of lung nodule [ Time Frame: 30 day ]
    no increased surgical morbidity from the operation


Eligibility Criteria
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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

    -

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04702165


Contacts
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Contact: Scott J Swanson, MD 617-525-7532 sjswanson@bwh.harvard.edu
Contact: Julianne Barlow, MS 617-525-8704 jbarlow1@bwh.harvard.edu

Locations
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United States, Massachusetts
Brigham and Women's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Scott Swanson, MD       sjswanson@bwh.harvard.edu   
Contact: Julianne Barlow, MS       jbarlow1@bwh.harvard.edu   
Sponsors and Collaborators
Navigation Sciences, Inc.
More Information
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Responsible Party: Navigation Sciences, Inc.
ClinicalTrials.gov Identifier: NCT04702165    
Other Study ID Numbers: 2020P002692
First Posted: January 8, 2021    Key Record Dates
Last Update Posted: April 8, 2022
Last Verified: August 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Navigation Sciences, Inc.:
lung nodule
lung cancer
lung mass
Additional relevant MeSH terms:
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Lung Diseases
Respiratory Tract Diseases