Image - Navigated Resection of Lung Nodules

NCT ID: NCT04702165

Last Updated: 2025-07-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-03

Study Completion Date

2022-06-16

Brief Summary

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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

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Conditions

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Lung Diseases

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

NONE

Study Groups

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VATS resection with J-bar

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

Group Type EXPERIMENTAL

lung resection with Lung Resection Marker Locator Kit

Intervention Type DEVICE

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

Interventions

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lung resection with Lung Resection Marker Locator Kit

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

Intervention Type DEVICE

Eligibility Criteria

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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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Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Navigation Sciences, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Brigham and Women's Hospital

Boston, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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2020P002692

Identifier Type: -

Identifier Source: org_study_id

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