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Clinical Trials in the USA / NCT06685133
Active, not recruiting Observational

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

NCT06685133 · tracked via the Priya Life Science USA tracker
Sponsor
Noah Medical
Phase
Observational
Started
2024-11-08
Last updated
2025-08-15

Condition(s) studied

Lung CancerLung; Nodule

Investigational drug(s) / intervention(s)

Robotic assisted bronchoscopy

Robotic assisted bronchoscopy: Subjects will undergo a robotic navigated bronchoscopy to biopsy peripheral pulmonary nodules.

Study summary

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

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Successful Navigation to the lesion — During the procedure
    Placing the scope in an adequate location which the physician operator judges as suitable to initiate biopsy.
  • Successful tool-in-lesion — During the procedure
    Successful tool-in-lesion (defined as the tool within the lesion) as confirmed by CBCT.
  • Serious Adverse Events — During the procedure and up to 7 days post procedure
    Serious device or procedure related adverse events

Trial sites (2)

FacilityCityRegionStatus
CHI Memorial Hospital Chattanooga Tennessee
Inova Fairfax Medical Campus Falls Church Virginia

Other trials for the same condition

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Evaluation of the Safety and Efficacy of Abenacianine (VGT-309) to Identify Cancer in Subjects Undergoing Surgery for Cancer in the Lung Recruiting
A Study of Valemetostat Tosylate Plus Pembrolizumab Versus Pembrolizumab Alone in First-Line NSCLC Without Actionable Genomic Alterations Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06685133 on ClinicalTrials.gov ↗ ← All trials in the USA