Image - Navigated Resection of Lung Nodules

NCT04702165 | Completed Phase 1 FDA Device

• 1 other identifier: 2020P002692
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Diseases

Keywords

lung nodule; lung cancer; lung mass

Outcome Measures

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).

  device feasibility

  1 day

Secondary Outcomes (3)

• whether coefficient is needed

  1 day

• time required for device placement

  1 day

• demonstrate safe surgical remove of lung nodule

  30 day

Study Arms (1)

VATS resection with J-bar

EXPERIMENTAL

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

Interventions

lung resection with Lung Resection Marker Locator Kit DEVICE

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

VATS resection with J-bar

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Navigation Sciences, Inc.: lead

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Lung Diseases; Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 23, 2020
• First Posted: January 8, 2021
• Study Start: June 3, 2021
• Primary Completion: June 16, 2022
• Study Completion: June 16, 2022
• Last Updated: July 29, 2025

Record last verified: 2025-07

Locations

US (1)