Image - Navigated Resection of Lung Nodules

Navigation Sciences, Inc.25 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DEVICE_FEASIBILITY

Masking

NONE

Enrollment

Conditions

Lung Diseases

Interventions

lung resection with Lung Resection Marker Locator KitDEVICE

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

Eligibility

Sex: ALLMin age: 21 Years

Medical Language ↔ Plain English

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 \-

Locations (1)

Brigham and Women's Hospital

Boston, Massachusetts, United States

Outcomes

Primary Outcomes

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

Time frame: 1 day

Secondary Outcomes

whether coefficient is needed

To determine whether a coefficient needs to be defined to harmonize the distance measured with the device to that found by pathologists

Time frame: 1 day

time required for device placement

3\. To determine the length of time needed for the placement of the device and record measurements.

Time frame: 1 day

demonstrate safe surgical remove of lung nodule

no increased surgical morbidity from the operation

Time frame: 30 day

Data from ClinicalTrials.gov

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