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

NCT06685133 | Active Not Recruiting FDA Device

• 1 other identifier: NOAH-003
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Lung Cancer; Lung; Nodule

Outcome Measures

Primary Outcomes (3)

• Successful Navigation to the lesion

  Placing the scope in an adequate location which the physician operator judges as suitable to initiate biopsy.

  During the procedure

• Successful tool-in-lesion

  Successful tool-in-lesion (defined as the tool within the lesion) as confirmed by CBCT.

  During the procedure

• Serious Adverse Events

  Serious device or procedure related adverse events

  During the procedure and up to 7 days post procedure

Secondary Outcomes (2)

• Diagnostic yield

  End of procedure and up to 2-years post-procedure

• Center Strike

  During the procedure

Study Arms (1)

Intervention/Treatment

Subjects who undergo bronchoscopy of the airways using the Galaxy System.

Device: Robotic assisted bronchoscopy

Interventions

Robotic assisted bronchoscopy DEVICE

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

Intervention/Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Clinic patients

You may qualify if:

• Age ≥ 18
• Patients with indeterminate lung nodule
• Peripheral pulmonary subsolid and solid nodules (PPNs) sized up to 3 cm measured as the largest dimension based on the pre-procedural CT
• Pre-procedural CT is conducted within 90 days of the bronchoscopy procedure
• Informed consent properly obtained per local regulations

You may not qualify if:

• Known pregnancy or breastfeeding
• Patients with pure ground-glass nodules on pre-procedural chest CT
• Uncontrolled coagulopathy or bleeding disorders
• Ongoing systemic infection
• History of lobectomy or pneumonectomy
• Patients with pacemakers or defibrillators
• Unsuitable for bronchoscopy procedure under general anesthesia as agreed by the treating clinician and anesthetist
• Patients with pleural effusion or diaphragmatic paralysis

Sponsors & Collaborators

• Noah Medical: lead

Study Sites (2)

CHI Memorial Hospital

Chattanooga, Tennessee, 37404, United States

Location

Inova Fairfax Medical Campus

Falls Church, Virginia, 22042, United States

Location

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2024
• First Posted: November 12, 2024
• Study Start: November 8, 2024
• Primary Completion: October 30, 2025
• Study Completion (Estimated): October 30, 2027
• Last Updated: August 15, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)