Image - Navigated Resection of Lung Nodules

Navigation Sciences

Status and phase: Completed; Phase 2; Phase 1

Conditions: Lung Diseases

Treatments: Device: lung resection with Lung Resection Marker Locator Kit

Study type: Interventional

Funder types: Industry

Identifiers

NCT04702165

2020P002692

Details and patient eligibility

About

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.

Enrollment: 25 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Device Feasibility

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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25 participants in 1 patient group

VATS resection with J-bar

Experimental group

Description:

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

Treatment:

Device: lung resection with Lung Resection Marker Locator Kit