CT-guided Needle Guidance Using Stereotaxic Unit, Navigation Versus Conventional Biopsy Technique… (NCT03321994) | Clinical Trial Compass
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CT-guided Needle Guidance Using Stereotaxic Unit, Navigation Versus Conventional Biopsy Technique for the Percutaneous Pulmonary Nodule Biopsy
106 participantsStarted 2017-11
Plain-language 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 undergo percutaneous pulmonary nodule biopsy.
Who can participate
Age range19 Years – 80 Years
SexALL
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Inclusion Criteria:
* 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 Criteria:
* 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