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

N/AActive Not RecruitingNCT06685133

Noah Medical50 enrolled

Overview

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

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

Conditions

Lung Cancer Lung; Nodule

Interventions

Robotic assisted bronchoscopyDEVICE

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (2)

CHI Memorial Hospital

Chattanooga, Tennessee, United States

Inova Fairfax Medical Campus

Falls Church, Virginia, United States

Outcomes

Primary Outcomes

Successful Navigation to the lesion

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

Time frame: During the procedure

Successful tool-in-lesion

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

Time frame: During the procedure

Serious Adverse Events

Serious device or procedure related adverse events

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

Secondary Outcomes

Diagnostic yield

Number of patients who are provided a definitive diagnosis based on the pathology report of the biopsied tissue.

Time frame: End of procedure and up to 2-years post-procedure

Center Strike

Center strike (defined as inner one-third of lesion from all 3 views (axial, sagittal, and coronal) confirmed by CBCT.

Time frame: During the procedure

Data from ClinicalTrials.gov

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