Image - Navigated Resection of Lung Nodules

Lung Diseases Clinical Trial

Official title:

Image - Navigated Resection of Lung Nodules

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04702165
• Other study ID #: 2020P002692
• Status: Active, not recruiting
• Phase: Phase 1/Phase 2
• Start date: June 3, 2021
• Est. completion date: December 2023

Study information

• Verified date: September 2022
• Source: Navigation Sciences, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 25
• Est. completion date: December 2023
• Est. primary completion date: April 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

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Related Conditions & MeSH terms

• Lung Diseases

Intervention

Device:
• lung resection with Lung Resection Marker Locator Kit
Nodules eligible for surgical resection using the Lung Resection Marker Locator Kit

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Navigation Sciences, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	1 day
Secondary	time required for device placement	3. To determine the length of time needed for the placement of the device and record measurements.	1 day
Secondary	demonstrate safe surgical remove of lung nodule	no increased surgical morbidity from the operation	30 day