NCT03716284

ENB for the Diagnosis of PPNs:a Real World Study

Electromagnetic Navigation Bronchoscopy for the Diagnosis of Peripheral Pulmonary Nodules: a Real World Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 479 (actual)
• Sponsor: Shanghai Chest Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The study is designed as a multi-center prospective trial of ENB for the diagnosis of peripheral pulmonary nodules in the real world. The purpose of the study is to identify the optimal method of using ENB.

Detailed description

The study will be conducted at no less than 5 clinical centers. Patients with peripheral pulmonary nodules suspicious for malignancy will be enrolled in the study. ENB will be performed with/without other guided bronchoscopy techniques and/or ROSE. Different biopsy methods will be recorded as well. The primary endpoint is the diagnostic yield of ENB. The secondary endpoints include factors affecting diagnostic yield, operation time, complications, safety and so on.

Conditions

• Peripheral Pulmonary Nodules

Interventions

Type	Name	Description
PROCEDURE	Electromagnetic navigation bronchoscopy (ENB)	ENB is carried out by a ENB system（LungCare, China) with/without other guided bronchoscopy techniques and/or ROSE, which can offer real-time navigation for bronchoscopy reaching peripheral pulmonary nodules.

Timeline

• Start date: 2019-03-20
• Primary completion: 2022-06-30
• Completion: 2022-06-30
• First posted: 2018-10-23
• Last updated: 2022-08-03

Locations

1 site across 1 country: China