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

Launched by NOAH MEDICAL · Nov 9, 2024

Keywords

ClinConnect Summary

This clinical trial is investigating a new technology called the Galaxy System, which helps doctors accurately examine lung nodules—small growths in the lungs that can be concerning but are often unclear in terms of diagnosis. The study aims to see how well this technology works in everyday medical practice, particularly for patients who have lung nodules that need further evaluation.

To be eligible for this trial, participants must be at least 18 years old and have a lung nodule that hasn’t been clearly identified yet. The nodules should be up to 3 centimeters in size, and patients must have had a CT scan done within the last month before the procedure. If you join the study, you can expect to undergo a procedure called bronchoscopy, where doctors will use the Galaxy System to help look at the nodule more closely. It’s important to know that some individuals may not qualify due to certain health conditions or situations, like being pregnant or having specific medical devices. Overall, this trial could provide valuable insights into better diagnosing and treating lung nodules.

Gender

ALL

Eligibility 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