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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 : September 5, 2021
Sponsor:
Information provided by (Responsible Party):
Navigation Sciences, Inc.

Tracking Information
First Submitted Date  ICMJE December 23, 2020
First Posted Date  ICMJE January 8, 2021
Last Update Posted Date September 5, 2021
Actual Study Start Date  ICMJE June 3, 2021
Estimated Primary Completion Date January 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 7, 2021)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 7, 2021)
  • 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
  • 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.
  • demonstrate safe surgical remove of lung nodule [ Time Frame: 30 day ]
    no increased surgical morbidity from the operation
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Image - Navigated Resection of Lung Nodules
Official Title  ICMJE Image - Navigated Resection of Lung Nodules
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Condition  ICMJE Lung Diseases
Intervention  ICMJE Device: lung resection with Lung Resection Marker Locator Kit
Nodules eligible for surgical resection using the Lung Resection Marker Locator Kit
Study Arms  ICMJE 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
Intervention: Device: lung resection with Lung Resection Marker Locator Kit
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 7, 2021)
25
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 2023
Estimated Primary Completion Date January 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

    -

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Scott J Swanson, MD 617-525-7532 sjswanson@bwh.harvard.edu
Contact: Julianne Barlow, MS 617-525-8704 jbarlow1@bwh.harvard.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04702165
Other Study ID Numbers  ICMJE 2020P002692
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Navigation Sciences, Inc.
Study Sponsor  ICMJE Navigation Sciences, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Navigation Sciences, Inc.
Verification Date August 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP