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ENB Vs. Conventional Bronchoscopy With Fluoroscopy for Safe and Effective Biopsy of Pulmonary Lesions

NCT04447482 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 212

Last updated 2021-03-18

No results posted yet for this study

Summary

Evaluate results for participants with lung lesions randomized to either 4D Electromagnetic Navigation Bronchoscopy (4D-ENB) versus Conventional Bronchoscopy with Fluoroscopy for diagnostic biopsy and detection of lung cancer.

Conditions

  • Lung Neoplasms
  • Pulmonary Neoplasm

Interventions

DEVICE

ENB with image-guided lung biopsy

Electromagnetic navigational bronchoscopy system with tip tracked instruments.

PROCEDURE

Conventional Bronchoscopy guided by Fluoroscopy

Bronchoscopic lung biopsy with fluoroscopy.

Sponsors & Collaborators

  • Shanghai Youhe Medical Technology Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Cathaly Hong · Shanghai Youhe Medical Technology Co., Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-10
Primary Completion
2021-06-30
Completion
2021-09-30
FDA Device
Yes

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04447482 on ClinicalTrials.gov