Prospective Evaluation of the Tool-in-lesion Technology of the Galaxy System in Routine Clinical Practice

Description

A prospective observational study evaluating the accuracy of the tool-in-lesion technology of the Galaxy SystemTM in normal clinical practice.

Conditions

Lung Cancer, Lung; Nodule

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Study Overview

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Study Details

Study overview

A prospective observational study evaluating the accuracy of the tool-in-lesion technology of the Galaxy SystemTM in normal clinical practice.

A Prospective Observational Study Evaluating the Accuracy of the Tool-in-lesion Technology of the Galaxy SystemTM in Normal Clinical Practice

Prospective Evaluation of the Tool-in-lesion Technology of the Galaxy System in Routine Clinical Practice

Condition
Lung Cancer
Intervention / Treatment

-

Contacts and Locations

Falls Church

Inova Fairfax Medical Campus, Falls Church, Virginia, United States, 22042

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. Age ≥ 18
  • 2. Patients with indeterminate lung nodule
  • 3. Peripheral pulmonary subsolid and solid nodules (PPNs) sized up to 3 cm measured as the largest dimension based on the pre-procedural CT
  • 4. Pre-procedural CT is conducted within 30 days of the bronchoscopy procedure
  • 5. Informed consent properly obtained per local regulations
  • 1. Known pregnancy or breastfeeding
  • 2. Patients with pure ground-glass nodules on pre-procedural chest CT
  • 3. Uncontrolled coagulopathy or bleeding disorders
  • 4. Ongoing systemic infection
  • 5. History of lobectomy or pneumonectomy
  • 6. Patients with pacemakers or defibrillators
  • 7. Unsuitable for bronchoscopy procedure under general anesthesia as agreed by the treating clinician and anesthetist
  • 8. Patients with pleural effusion or diaphragmatic paralysis

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Noah Medical,

Study Record Dates

2027-02-28