CT-guided Needle Guidance Using Stereotaxic Unit, Navigation Versus Conventional Biopsy Technique for the Percutaneous Pulmonary Nodule Biopsy
NCT ID: NCT03321994
Last Updated: 2017-10-26
Study Results
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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UNKNOWN
NA
106 participants
INTERVENTIONAL
2017-11-30
2019-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
SINGLE
Study Groups
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Stereotaxic unit, navigation
stereotaxic unit, navigation
CT-guided needle guidance using stereotaxic unit, navigation
Conventional biopsy technique
conventional biopsy technique
CT-guided needle guidance using conventional biopsy technique
Interventions
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stereotaxic unit, navigation
CT-guided needle guidance using stereotaxic unit, navigation
conventional biopsy technique
CT-guided needle guidance using conventional biopsy technique
Eligibility Criteria
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Inclusion Criteria
* Histopathologic examination is necessary if lung lesion is unknown
* Histologic findings affect the disease stage or treatment plan
* If the investigator decides to perform a percutaneous lung biopsy because the biopsy or diagnosis through the bronchoscopy is not possible or has low risk-benefit
* Patient who have consented to contraception during the period of clinical trial participation (one month after the procedure)
* Patient who voluntarily agree to participate in this clinical trial and are willing to comply with the protocol
Exclusion Criteria
* Patient who has difficulty in self-breathing (e.g, breathing through oxygen breathing apparatus)
* Patient with Uncontrolled coagulation disorders (INR \> 1.3 or Blood platelet count \< 50,000/µl)
* Patient with allergy to CT contrast agent
* Patient under 19 years old or over 80 years old
* Pregnant or lactating
* Patient with uncontrollable systemic disease (e.g, uncontrolled hypertension, uncontrolled cardiovascular disease, etc.)
* Patient who currently participating or has participated in other clinical trials within 30 days of the screening date
* If it is judged inappropriate to participate in this clinical trial under the judgment of the investigator
19 Years
80 Years
ALL
No
Sponsors
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Hyung Jin Won
OTHER
Responsible Party
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Hyung Jin Won
Professor
Principal Investigators
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Hyung Jin Won, MD., PhD
Role: PRINCIPAL_INVESTIGATOR
Asan Medical Center, Seoul, Korea
Central Contacts
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Other Identifiers
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AS-NPR-03
Identifier Type: -
Identifier Source: org_study_id