NCT05799014

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2023

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 8, 2023

Completed
22 days until next milestone

Study Start

First participant enrolled

March 30, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 5, 2023

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 24, 2024

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

April 5, 2023

Status Verified

March 1, 2023

Enrollment Period

1.7 years

First QC Date

March 8, 2023

Last Update Submit

March 22, 2023

Conditions

Peripheral Lung Lesions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Operation time

    during the operation of lung biopsy

Study Arms (2)

Traditional CT-guided percutaneous lung biopsy group

EXPERIMENTAL
Procedure: CT-guided percutaneous lung biopsy

Percutaneous lung biopsy guided by electromagnetic navigation real-time positioning technology group

EXPERIMENTAL
Procedure: Percutaneous lung biopsy guided by electromagnetic navigation real-time positioning technology

Interventions

CT-guided percutaneous lung biopsyPROCEDURE

The participants would undergo CT-guided percutaneous lung biopsy.

Traditional CT-guided percutaneous lung biopsy group
Percutaneous lung biopsy guided by electromagnetic navigation real-time positioning technologyPROCEDURE

The participants would undergo percutaneous lung biopsy guided by electromagnetic navigation real-time positioning technology.

Percutaneous lung biopsy guided by electromagnetic navigation real-time positioning technology group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Central Study Contacts

Mingming Deng, MD

CONTACT

86 18801336854isdeng1017@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 8, 2023

First Posted

April 5, 2023

Study Start

March 30, 2023

Primary Completion

December 24, 2024

Study Completion

December 31, 2024

Last Updated

April 5, 2023

Record last verified: 2023-03