Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 1:38 AM
Ignite Modification Date:
2025-12-25 @ 1:38 AM
NCT ID:
NCT04250194
Brief 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).
Study:
NCT04250194
Study Brief:
Protocol Section:
NCT04250194