Trials / Unknown
UnknownNCT04447482
ENB Vs. Conventional Bronchoscopy With Fluoroscopy for Safe and Effective Biopsy of Pulmonary Lesions
A Prospective, Randomized, Multi-center, Superiority Clinical Study to Evaluate the Effectiveness and Safety of Bronchoscopic Lung Biopsy Under the Guide of CT Stereotactic Auxiliary Equipment and Accessories
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 212 (estimated)
- Sponsor
- Shanghai Youhe Medical Technology Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
The objective of this clinical trial is to evaluate the safety and efficacy results for two bronchoscopic biopsy techniques for sampling lung lesions: either image-guided electromagnetic navigation or conventional bronchoscopy with fluoroscopy. The diagnostic yield and adverse events of participants prospectively randomized to either arm will be evaluated. This is a prospective, randomized, multi-center study.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2020-07-10
- Primary completion
- 2021-06-30
- Completion
- 2021-09-30
- First posted
- 2020-06-25
- Last updated
- 2021-03-18
Locations
4 sites across 1 country: China
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04447482. Inclusion in this directory is not an endorsement.