Evaluating the Galaxy System for Lung Nodule Biopsies
A Prospective Observational Study Evaluating the Accuracy of the Tool-in-lesion Technology of the Galaxy SystemTM in Normal Clinical Practice
This study is testing a new robotic tool to see if it can help doctors safely and accurately take biopsies from small lung nodules in patients with unclear results.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Noah Medical Industry-sponsored |
| Locations | 2 sites (Chattanooga, Tennessee and 1 other locations) |
| Trial ID | NCT06685133 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the accuracy and effectiveness of the Galaxy System's tool-in-lesion technology during routine clinical practice for bronchoscopically biopsying small peripheral pulmonary nodules. It will collect clinical data from eligible patients to confirm the safety and efficacy of this robotic-assisted bronchoscopy approach. The study focuses on patients with indeterminate lung nodules and will utilize pre-procedural CT scans to guide the procedures.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with indeterminate peripheral pulmonary nodules sized up to 3 cm.
Not a fit: Patients with pure ground-glass nodules, uncontrolled coagulopathy, or those unsuitable for bronchoscopy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the accuracy of lung nodule biopsies, leading to better diagnosis and treatment options for patients with lung cancer.
How similar studies have performed: Other studies have shown promise in using robotic-assisted bronchoscopy for lung nodule biopsies, suggesting a potential for success with this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion 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 90 days of the bronchoscopy procedure 5. Informed consent properly obtained per local regulations Exclusion Criteria: 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
Where this trial is running
Chattanooga, Tennessee and 1 other locations
- CHI Memorial Hospital — Chattanooga, Tennessee, United States (Recruiting)
- Inova Fairfax Medical Campus — Falls Church, Virginia, United States (Recruiting)
Study contacts
- Study coordinator: Lilach Ofri
- Email: lilachofri@noahmed.com
- Phone: 408-483-3994
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.