NCT04250194

Navigation Endoscopy to Reach Indeterminate Lung Nodules Versus Trans-Thoracic Needle Aspiration

Navigation Endoscopy to Reach Indeterminate Lung Nodules Versus Trans-Thoracic Needle Aspiration, a Randomized Controlled Study (VERITAS)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 288 (actual)
• Sponsor: Vanderbilt-Ingram Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate which procedure is the best for patients referred for biopsy of a lung nodule (growth in the lung) meeting the size and location requirements of the protocol. Two different procedures are available for lung nodule biopsy: 1. a computed tomography guided biopsy ("CT-guided biopsy") which consists of sampling the nodule from the "outside-in", through the chest wall with CT guidance, and 2. navigation bronchoscopy, which is a procedure using technology designed to guide a catheter through the natural airway route (wind-pipe and bronchi) to access the nodule.

Detailed description

Endpoints: Primary: • To evaluate diagnostic accuracy through 12 months of clinical follow-up Secondary: * To evaluate rate of pneumothorax. * To evaluate rate of pneumothorax requiring chest tube placement. * To evaluate clinically significant bleeding (defined by bleeding requiring intervention). * To evaluate need for hospitalization after procedure. * To evaluate duration of the procedure. * To evaluate procedural factors associated with improved yield (type of biopsy, number of biopsies, use of radial ultrasound, presence of a bronchus sign, biopsy site). * To evaluate need for additional nodule biopsy. * To evaluate need for additional procedure for staging. * To evaluate radiation exposure from fluoroscopy-guided bronchoscopy and CT for CT-guided biopsy. * To evaluate need for F-Nav (digital tomosynthesis) during navigation bronchoscopy. * To evaluate diagnostic yield * To evaluate the rate at which the biopsy procedure yields a confident clinical diagnosis (including any added yield from endobronchial ultrasound-guided mediastinal and/or hilar lymph node biopsies or microbiologic studies which yield an explanation for a nodule despite non-diagnostic biopsy specimens).

Conditions

• Lung Nodule

Interventions

Type	Name	Description
DEVICE	CT-Guided Biopsy	Images will be generated by a CT scanner to accurately insert a needle into the lung nodule allowing a sample to be removed for testing
DEVICE	Navigation bronchoscopy	A virtual three-dimensional map of the lung will be generated enabling the physician to perform an anatomically precise biopsy

Timeline

• Start date: 2020-05-22
• Primary completion: 2024-06-10
• Completion: 2024-07-02
• First posted: 2020-01-31
• Last updated: 2025-09-29
• Results posted: 2025-07-14

Locations

7 sites across 1 country: United States

Regulatory

• FDA-regulated device study