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OpenTrials
Completed

NCT Number: NCT04702165

Image - Navigated Resection of Lung Nodules

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.

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Key information

Conditions

Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

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Treatment and study plan

lung resection with Lung Resection Marker Locator Kit

Device

Nodules eligible for surgical resection using the Lung Resection Marker Locator Kit

Primary outcomes

  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 outcomes

  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

    • 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

Sponsors and collaborators

Lead sponsor

Navigation Sciences, Inc.

Industry

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jan 8, 2021
Registry last updated
Jul 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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