Status:
UNKNOWN
CT-guided Needle Guidance Using Stereotaxic Unit, Navigation Versus Conventional Biopsy Technique for the Percutaneous Pulmonary Nodule Biopsy
Lead Sponsor:
Hyung Jin Won
Conditions:
Percutaneous Pulmonary Nodule Biopsy
Eligibility:
All Genders
19-80 years
Phase:
NA
Brief Summary
The purpose of this study was to compare the safety and efficacy of CT-guided needle guidance using stereotaxic unit, navigation versus conventional biopsy technique for the patients scheduled to unde...
Eligibility Criteria
Inclusion
- Patient with localized lesions such as pulmonary nodules on chest x-ray, CT or PET CT
- 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
- Patient with pulmonary function insufficiency
- 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
Key Trial Info
Start Date :
November 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2019
Estimated Enrollment :
106 Patients enrolled
Trial Details
Trial ID
NCT03321994
Start Date
November 1 2017
End Date
June 1 2019
Last Update
October 26 2017
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