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

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

106 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-30

Study Completion Date

2019-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Percutaneous Pulmonary Nodule Biopsy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Stereotaxic unit, navigation

Group Type EXPERIMENTAL

stereotaxic unit, navigation

Intervention Type DEVICE

CT-guided needle guidance using stereotaxic unit, navigation

Conventional biopsy technique

Group Type ACTIVE_COMPARATOR

conventional biopsy technique

Intervention Type DEVICE

CT-guided needle guidance using conventional biopsy technique

Interventions

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stereotaxic unit, navigation

CT-guided needle guidance using stereotaxic unit, navigation

Intervention Type DEVICE

conventional biopsy technique

CT-guided needle guidance using conventional biopsy technique

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hyung Jin Won

OTHER

Sponsor Role lead

Responsible Party

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Hyung Jin Won

Professor

Responsibility Role SPONSOR_INVESTIGATOR

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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Hyung Jin Won, MD., PhD

Role: CONTACT

Phone: 82-2-3010-4352

Email: [email protected]

Sang Young Oh, MD., PhD

Role: CONTACT

Phone: 82-2-3010-4352

Email: [email protected]

Other Identifiers

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AS-NPR-03

Identifier Type: -

Identifier Source: org_study_id