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NCT Number: NCT06685133

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

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

Active, not recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHI Memorial Hospital, Chattanooga, Tennessee, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Robotic assisted bronchoscopy

Device

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

Primary outcomes

  1. 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.

  2. Successful tool-in-lesion

    Time frame: During the procedure

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

  3. Serious Adverse Events

    Time frame: During the procedure and up to 7 days post procedure

    Serious device or procedure related adverse events

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Noah Medical

Industry

Registry information

Official study title

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

Acronym: Match 2

Important dates

Study start
2024
Primary completion
2025
Study completion
2027
First posted
Nov 12, 2024
Registry last updated
Aug 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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