Prospective Evaluation of the Tool-in-lesion Technology of the Galaxy System in Routine Clinical Practice (Match 2)

August 13, 2025 updated by: Noah Medical

A Prospective Observational Study Evaluating the Accuracy of the Tool-in-lesion Technology of the Galaxy SystemTM in Normal Clinical Practice

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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Tennessee
      • Chattanooga, Tennessee, United States, 37404
        • CHI Memorial Hospital
    • Virginia
      • Falls Church, Virginia, United States, 22042
        • Inova Fairfax Medical Campus

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Clinic patients

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Intervention/Treatment
Subjects who undergo bronchoscopy of the airways using the Galaxy System.
Device: Robotic assisted bronchoscopy
Subjects will undergo a robotic navigated bronchoscopy to biopsy peripheral pulmonary nodules.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnostic yield
Time Frame: 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.
End of procedure and up to 2-years post-procedure
Center Strike
Time Frame: During the procedure
Center strike (defined as inner one-third of lesion from all 3 views (axial, sagittal, and coronal) confirmed by CBCT.
During the procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Noah Medical

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 8, 2024

Primary Completion (Estimated)

October 30, 2025

Study Completion (Estimated)

October 30, 2027

Study Registration Dates

First Submitted

November 9, 2024

First Submitted That Met QC Criteria

November 9, 2024

First Posted (Actual)

November 12, 2024

Study Record Updates

Last Update Posted (Estimated)

August 15, 2025

Last Update Submitted That Met QC Criteria

August 13, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • NOAH-003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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