Status:
UNKNOWN
ENB Vs. Conventional Bronchoscopy With Fluoroscopy for Safe and Effective Biopsy of Pulmonary Lesions
Lead Sponsor:
Shanghai Youhe Medical Technology Co., Ltd.
Conditions:
Lung Neoplasms
Pulmonary Neoplasm
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief 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...
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...
Eligibility Criteria
Inclusion
- Subjects must meet all of the following criteria to be selected:
- Be older than 18 (including 18) and younger than 75 (including 75);
- The population with peripheral lung lesions detected in chest CT scanning and who require biopsy;
- The subjects are willing to undergo bronchoscopy and meet the requirements for bronchoscopy;
- The subjects or their guardians can understand the trial objective, volunteer to participate and sign the informed consent form.
Exclusion
- Subjects will be excluded if they meet any of the following criteria:
- The patient is participating in another drug or medical device clinical trial (drug clinical trial within 3 months or medical device clinical trial within 1 month);
- Women of childbearing age who have positive pregnancy test result and lactating women;
- Allergic to anesthetics;
- Bronchoscopy contraindications, including: active massive hemoptysis; recent myocardial infarction or unstable angina pectoris; severe heart and lung dysfunction; severe hypertension and arrhythmia; uncorrectable bleeding tendency (such as severe coagulation disorders, uremia and severe pulmonary hypertension); severe superior vena cava obstruction syndrome; suspected aortic aneurysm; multiple pulmonary bullae; systemically extreme exhaustion.
- Visible intraluminal lesions found during bronchoscopy;
- Patients with severe lung diseases (including: severe bronchodilatation, severe emphysema, etc.) and patients determined to be unsuitable for the examination by the investigators;
- Patients with a pacemaker or defibrillator;
- Patients who cannot cooperate with the doctor to complete bronchoscopy, such as patients with mental and neurological diseases, mental retardation and mental disorders;
- Patients to whom bronchoscopy and bronchoscopic sampling are not applicable to diagnose the lesions, or other patients determined to be unsuitable for this trial by the investigators.
Key Trial Info
Start Date :
July 10 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2021
Estimated Enrollment :
212 Patients enrolled
Trial Details
Trial ID
NCT04447482
Start Date
July 10 2020
End Date
September 30 2021
Last Update
March 18 2021
Active Locations (4)
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1
The First Affiliated Hospital, Zhejiang University School of Medicine
Hanzhou, Zhejiang, China
2
Shanghai Changhai Hospital
Shanghai, China
3
Shanghai Chest Hospital
Shanghai, China
4
Shanghai East Hospital
Shanghai, China