Peripheral Lung LesionsNCT05799014
The Effectiveness and Safety of Electromagnetic Navigation Real-time Guided Percutaneous Lung Biopsy
A study testing CT-guided percutaneous lung biopsy and Percutaneous lung biopsy guided by electromagnetic navigation real-time positioning technology in people with Peripheral Lung Lesions, run by China-Japan Friendship Hospital.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Peripheral Lung Lesions
- What is being tested?
- CT-guided percutaneous lung biopsy and Percutaneous lung biopsy guided by electromagnetic navigation real-time positioning technology
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 30 Mar 2023to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Effectiveness and Safety of Percutaneous Lung Biopsy Guided by Electromagnetic Navigation Real-time Positioning Technology
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.
- Conditions
- Peripheral Lung Lesions
- Being tested
- CT-guided percutaneous lung biopsy, Percutaneous lung biopsy guided by electromagnetic navigation real-time positioning technology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT-guided percutaneous lung biopsyProcedure or surgery
The participants would undergo CT-guided percutaneous lung biopsy.
Percutaneous lung biopsy guided by electromagnetic navigation real-time positioning technologyProcedure or surgery
The participants would undergo percutaneous lung biopsy guided by electromagnetic navigation real-time positioning technology.
| Study group | Role | What they receive |
|---|---|---|
| Traditional CT-guided percutaneous lung biopsy group | Experimental | Not described Receives: Procedure: CT-guided percutaneous lung biopsy |
| Percutaneous lung biopsy guided by electromagnetic navigation real-time positioning technology group | Experimental | Not described Receives: Procedure: Percutaneous lung biopsy guided by electromagnetic navigation real-time positioning technology |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 7 days after the lung biopsy
Secondary outcomes (1)
Operation time
Timer
Measured: during the operation of lung biopsy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2023
- Study start30 Mar 2023 (estimated)
- Primary completion24 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Lung LesionsStudies of the same condition, open and under way.
- More trials run by China-Japan Friendship HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China-Japan Friendship Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gang Hou, China-Japan Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05799014
- Sponsor's protocol ID
- 2022-NHLHCRF-LX-01-0201-01
- Status last verified
- Mar 2023
- First submitted
- 8 Mar 2023
- Last updated
- 5 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness and Safety of Percutaneous Lung Biopsy Guided by Electromagnetic Navigation Real-time Positioning Technology
- ClinicalTrials.gov ID
- NCT05799014
- Acronym / sponsor ID
- 2022-NHLHCRF-LX-01-0201-01
- Conditions
- Peripheral Lung Lesions
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- China-Japan Friendship HospitalUniversity, hospital or other
- Study start
- 30 Mar 2023 (estimated)
- Primary completion
- 24 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 5 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CT-guided percutaneous lung biopsyThe participants would undergo CT-guided percutaneous lung biopsy. | Procedure or surgery | Traditional CT-guided percutaneous lung biopsy group |
| Percutaneous lung biopsy guided by electromagnetic navigation real-time positioning technologyThe participants would undergo percutaneous lung biopsy guided by electromagnetic navigation real-time positioning technology. | Procedure or surgery | Percutaneous lung biopsy guided by electromagnetic navigation real-time positioning technology group |
Primary outcome
Diagnostic accuracy of percutaneous lung biopsy guided by electromagnetic navigation real-time positioning technology for diagnosis of pleural effusion.
Time frame: 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.
1 secondary outcome
Operation time
Time frame: during the operation of lung biopsy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing CT-guided percutaneous lung biopsy and Percutaneous lung biopsy guided by electromagnetic navigation real-time positioning technology in people with Peripheral Lung Lesions, run by China-Japan Friendship Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mingming Deng, MD (86 18801336854, isdeng1017@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic accuracy of percutaneous lung biopsy guided by electromagnetic navigation real-time positioning technology for diagnosis of pleural effusion. (time frame: 7 days after the lung biopsy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2023.