Image - Navigated Resection of Lung Nodules

Phase 1

Active, not recruiting

• Conditions: Lung Diseases
• Interventions: Device: lung resection with Lung Resection Marker Locator Kit

• Registration Number: NCT04702165
• Lead Sponsor: Navigation Sciences, Inc.

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 available

Study Timeline

• Study First Submitted: 2020-12-23
• Study First Submitted QC: 2021-01-07
• Study First Posted: 2021-01-08
• Study Start: 2021-06-03
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-27
• Last Update Posted: 2022-09-28
• Primary Completion: 2023-04
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 25

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
VATS resection with J-bar	lung resection with Lung Resection Marker Locator Kit	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

Primary Outcome Measures

Name	Time	Method
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).	1 day	device feasibility

Secondary Outcome Measures

Name	Time	Method
demonstrate safe surgical remove of lung nodule	30 day	no increased surgical morbidity from the operation
time required for device placement	1 day	3. To determine the length of time needed for the placement of the device and record measurements.
whether coefficient is needed	1 day	To determine whether a coefficient needs to be defined to harmonize the distance measured with the device to that found by pathologists

Trial Locations

Locations (1)

Brigham and Women's Hospital; 🇺🇸 Boston, Massachusetts, United States