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

NCT ID: NCT06685133

Last Updated: 2025-08-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-11-08

Study Completion Date

2027-10-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Lung Cancer Lung; Nodule

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Intervention/Treatment

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

Robotic assisted bronchoscopy

Intervention Type DEVICE

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

Interventions

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Robotic assisted bronchoscopy

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Noah Medical

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CHI Memorial Hospital

Chattanooga, Tennessee, United States

Site Status

Inova Fairfax Medical Campus

Falls Church, Virginia, United States

Site Status

Countries

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United States

Other Identifiers

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NOAH-003

Identifier Type: -

Identifier Source: org_study_id

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