NCT03569306

ENB in the Diagnosis of Peripheral Pulmonary Nodules

Electromagnetic Navigation Bronchoscopy in the Diagnosis of Peripheral Pulmonary Nodules

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 400 (estimated)
• 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 with two arms, ENB-EBUS-GS group and EBUS-GS group, and aimed to evaluate the diagnostic yield and operation time between the two groups.

Detailed description

The study is designed as a multi-center prospective trial with two arms, ENB-EBUS-GS group and EBUS-GS group, and aimed to evaluate the diagnostic yield and operation time between the two groups. Patients with peripheral pulmonary nodules that need to be confirmed by pathology will be enrolled in the study. A total of 400 patients are expected to be enrolled. EBUS will be used in both group. Biopsy, brushing and washing will be performed when EBUS image present. Brushing, washing and lavage will be performed when EBUS image absent.

Conditions

• Peripheral Pulmonary Nodules

Interventions

Type	Name	Description
DEVICE	ENB	ENB is carried out by a ENB system（LungCare, China) which can offer real-time navigation for bronchoscopy reaching peripheral pulmonary nodules.
DEVICE	EBUS-GS	EBUS is performed using an endoscope ultrasound system , which is equipped with a 20-MHz mechanical radial-type probe (UM-S20-17S;Olympus) with an external diameter of 1.4 mm and a GS (K-201; Olympus).

Timeline

• Start date: 2018-07-04
• Primary completion: 2019-12-30
• Completion: 2019-12-30
• First posted: 2018-06-26
• Last updated: 2018-07-06

Locations

1 site across 1 country: China