Prospective Evaluation of the Tool-in-lesion Technology of the Galaxy System in Routine Clinical Practice
NCT ID: NCT06685133
Last Updated: 2025-08-15
Study Results
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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ACTIVE_NOT_RECRUITING
50 participants
OBSERVATIONAL
2024-11-08
2027-10-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Intervention/Treatment
Subjects who undergo bronchoscopy of the airways using the Galaxy System.
Robotic assisted bronchoscopy
Subjects will undergo a robotic navigated bronchoscopy to biopsy peripheral pulmonary nodules.
Interventions
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Robotic assisted bronchoscopy
Subjects will undergo a robotic navigated bronchoscopy to biopsy peripheral pulmonary nodules.
Eligibility Criteria
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Inclusion Criteria
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 90 days of the bronchoscopy procedure
5. Informed consent properly obtained per local regulations
Exclusion Criteria
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
18 Years
ALL
No
Sponsors
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Noah Medical
INDUSTRY
Responsible Party
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Locations
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CHI Memorial Hospital
Chattanooga, Tennessee, United States
Inova Fairfax Medical Campus
Falls Church, Virginia, United States
Countries
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Other Identifiers
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NOAH-003
Identifier Type: -
Identifier Source: org_study_id
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