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

Sponsor
China-Japan Friendship Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05799014
Collaborator
(none)
200
Enrollment
2
Arms
21.1
Anticipated Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: CT-guided percutaneous lung biopsy
  • Procedure: Percutaneous lung biopsy guided by electromagnetic navigation real-time positioning technology
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
200 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
The Effectiveness and Safety of Percutaneous Lung Biopsy Guided by Electromagnetic Navigation Real-time Positioning Technology
Anticipated Study Start Date :
Mar 30, 2023
Anticipated Primary Completion Date :
Dec 24, 2024
Anticipated Study Completion Date :
Dec 31, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Traditional CT-guided percutaneous lung biopsy group

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

Procedure: 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.

Outcome Measures

Primary Outcome Measures

  1. Diagnostic accuracy of percutaneous lung biopsy guided by electromagnetic navigation real-time positioning technology for diagnosis of pleural effusion. [7 days after the lung biopsy]

    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.

Secondary Outcome Measures

  1. Operation time [during the operation of lung biopsy]

    Timer

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • China-Japan Friendship Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Gang Hou, Principal Investigator, China-Japan Friendship Hospital
ClinicalTrials.gov Identifier:
NCT05799014
Other Study ID Numbers:
  • 2022-NHLHCRF-LX-01-0201-01
First Posted:
Apr 5, 2023
Last Update Posted:
Apr 5, 2023
Last Verified:
Mar 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Apr 5, 2023