The Effectiveness and Safety of Electromagnetic Navigation Real-time Guided Percutaneous Lung Biopsy

Peripheral Lung Lesions Clinical Trial

Official title:

The Effectiveness and Safety of Percutaneous Lung Biopsy Guided by Electromagnetic Navigation Real-time Positioning Technology

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05799014
• Other study ID #: 2022-NHLHCRF-LX-01-0201-01
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 30, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: March 2023
• Source: China-Japan Friendship Hospital
• Contact: Mingming Deng, MD
• Phone: 86 18801336854
• Email: isdeng1017[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this clinical trial is to evaluate the diagnostic efficacy and safety of percutaneous lung biopsy guided by electromagnetic navigation real-time positioning technology in peripheral lung lesions. The main question it aims to answer are: the effectiveness and safety of percutaneous lung biopsy guided by electromagnetic navigation real-time positioning technology.

Participants will undergo CT-guided percutaneous lung biopsy or percutaneous lung biopsy guided by electromagnetic navigation real-time positioning technology.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: December 31, 2024
• Est. primary completion date: December 24, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Age 18-80 years old

• Imaging examination showed peripheral lung lesions

• Selected patients need to complete routine preoperative examinations such as blood routine examination, coagulation function, electrocardiogram, chest CT, etc

• There is no contraindication for puncture biopsy

• Good compliance, able to cooperate with research and observation

• Fully informed of the purpose and method of the study, agreed to participate in the study, and signed the informed consent form

Exclusion Criteria:

• Severe cardiopulmonary insufficiency, extreme weakness and intolerance of patients

• The patient is allergic to lidocaine and midazolam

• The site to be biopsied has a high risk of bleeding such as bronchial artery penetration or suspected lung metastasis of renal cancer

• Unstable angina pectoris, congestive heart failure, severe bronchial asthma

• The patient did not agree to participate in the study

• Participation in other studies within three months without withdrawal or termination will affect the observation of this study

• The researcher believes that there is any person who is not suitable for the selection

Related Conditions & MeSH terms

• Peripheral Lung Lesions

Intervention

Procedure:
• CT-guided percutaneous lung biopsy
The participants would undergo CT-guided percutaneous lung biopsy.
• Percutaneous lung biopsy guided by electromagnetic navigation real-time positioning technology
The participants would undergo percutaneous lung biopsy guided by electromagnetic navigation real-time positioning technology.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
China-Japan Friendship Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnostic accuracy of percutaneous lung biopsy guided by electromagnetic navigation real-time positioning technology for diagnosis of pleural effusion.	The diagnosis would be confirmed according to the pathological results or multidisciplinary discussion results (if interstitial lung disease is suspected, the multidisciplinary discussion results shall be recorded).; The diagnostic efficacy of percutaneous lung biopsy guided by electromagnetic navigation real-time positioning technology will be compared with that of CT-guided percutaneous lung biopsy for diagnosis of pleural effusion.	7 days after the lung biopsy
Secondary	Operation time	Timer	during the operation of lung biopsy