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

Recruiting

• Conditions: Lung Cancer; Lung; Nodule

• Registration Number: NCT06685133
• Lead Sponsor: Noah Medical

Brief Summary

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

Detailed Description

The goal of this study is to collect clinical data from eligible subjects in routine clinical practice to confirm the safety and effectiveness of the Galaxy SystemTM with integrated tool-in-lesion tomography (TiLT+) in bronchoscopically biopsying small peripheral pulmonary nodules.

Study Timeline

• Study Start: 2024-11-08
• Study First Submitted: 2024-11-09
• Study First Submitted QC: 2024-11-09
• Study First Posted: 2024-11-12
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-22
• Last Update Posted: 2025-04-23
• Primary Completion: 2025-10-30
• Study Completion: 2027-10-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
Diagnostic yield	End of procedure and up to 2-years post-procedure	Number of patients who are provided a definitive diagnosis based on the pathology report of the biopsied tissue.
Center Strike	During the procedure	Center strike (defined as inner one-third of lesion from all 3 views (axial, sagittal, and coronal) confirmed by CBCT.

Trial Locations

Locations (2)

CHI Memorial Hospital; 🇺🇸 Chattanooga, Tennessee, United States

Inova Fairfax Medical Campus; 🇺🇸 Falls Church, Virginia, United States