NCT04692038

Evaluate the Diagnostic Value of Puncture Biopsy for PPL Under the Guidance of Navigation and Radial EBUS: a Real-World Study

A Real-World Study to Evaluate the Diagnostic Value of Puncture Biopsy for Peripheral Lung Nodules Under the Guidance of Augmented Reality Navigation System Combined With Radial EBUS

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 50 (estimated)
• Sponsor: Guangzhou Institute of Respiratory Disease · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

Summary

The study is designed to evaluate the safety and effectiveness of biopsy forceps combined with puncture biopsy for the diagnosis of peripheral pulmonary nodules under the guidance of Augmented Reality Navigation System combined with radial endobronchial ultrasound (r-EBUS), and to explore the factors influencing the diagnosis rate.

Detailed description

The study will last for no longer than 12 months. Patients will be first screened, and only after meeting all the inclusion criteria, not meeting any exclusion criteria, and signing the informed consent, could they be enrolled in the group to receive forceps biopsy combined with puncture biopsy to sample the target nodules. The primary endpoint is the combined diagnostic yield of forceps biopsy and puncture biopsy. The secondary endpoints include the success rate of biopsy, the operation time of the bronchoscope and so on.

Conditions

• Lung; Nodes

Interventions

Type	Name	Description
DEVICE	Forceps biopsy combined with puncture biopsy under the guidance of Augmented Reality Navigation and Radial EBUS	During the operation, under the guidance of Augmented Reality Navigation, the bronchoscope will reach the location of the target pulmonary nodules, and the EBUS probe will be inserted through the bronchoscope working channel, and gradually approach the target nodules to obtain EBUS images. After typical EBUS images are observed and the location is confirmed, the EBUS probe will be withdrawn and biopsy forceps and puncture biopsy needle will be used to obtain samples at the target locations respectively.

Timeline

• Start date: 2021-01-10
• Primary completion: 2021-12-20
• Completion: 2022-03-20
• First posted: 2020-12-31
• Last updated: 2021-01-06

Locations

1 site across 1 country: China