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

NCT ID: NCT05799014

Last Updated: 2023-04-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-30

Study Completion Date

2024-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Peripheral Lung Lesions

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Traditional CT-guided percutaneous lung biopsy group

Group Type EXPERIMENTAL

CT-guided percutaneous lung biopsy

Intervention Type PROCEDURE

The participants would undergo CT-guided percutaneous lung biopsy.

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

Group Type EXPERIMENTAL

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

Intervention Type PROCEDURE

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

Interventions

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CT-guided percutaneous lung biopsy

The participants would undergo CT-guided percutaneous lung biopsy.

Intervention Type 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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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China-Japan Friendship Hospital

OTHER

Sponsor Role lead

Responsible Party

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Gang Hou

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Mingming Deng, MD

Role: CONTACT

86 18801336854

Other Identifiers

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2022-NHLHCRF-LX-01-0201-01

Identifier Type: -

Identifier Source: org_study_id

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