Percutaneous Pulmonary Nodule BiopsyNCT03321994
CT-guided Needle Guidance Using Stereotaxic Unit, Navigation Versus Conventional Biopsy Technique for the Percutaneous Pulmonary Nodule Biopsy
A study testing stereotaxic unit, navigation and conventional biopsy technique in people with Percutaneous Pulmonary Nodule Biopsy, run by Hyung Jin Won.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 80 years
- Conditions the study is for
- Percutaneous Pulmonary Nodule Biopsy
- What is being tested?
- stereotaxic unit, navigation and conventional biopsy technique
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- No sites listed yet
- Study dates
- Nov 2017to Jun 2019
- 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 19 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Single-center, Randomized, Active-controlled and Evaluator-blind Investigator-initiated Trial to Evaluate and Compare the Efficacy and Safety of CT-guided Needle Guidance Using Stereotaxic Unit, Navigation Versus Conventional Biopsy Technique for the Patients Scheduled to Undergo Percutaneous Pulmonary Nodule Biopsy
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.
- Conditions
- Percutaneous Pulmonary Nodule Biopsy
- Being tested
- stereotaxic unit, navigation, conventional biopsy technique
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
stereotaxic unit, navigationDevice
CT-guided needle guidance using stereotaxic unit, navigation
conventional biopsy techniqueDevice
CT-guided needle guidance using conventional biopsy technique
| Study group | Role | What they receive |
|---|---|---|
| Stereotaxic unit, navigation | Experimental | Not described Receives: Device: stereotaxic unit, navigation |
| Conventional biopsy technique | Active comparator | Not described Receives: Device: conventional biopsy technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Needle guide accuracy(mm)
3D distance between target point and actual needle tip
Measured: 1 day
Secondary outcomes (5)
Needle guide angle deviation(°)
The angle deviation between the needle insertion path on the procedure plan and the path of the actually inserted needle
Measured: 1 day
Number of needle readjustments
Retract the inserted needle and adjust the direction
Measured: 1 day
Number of needle reinsertion
Needle is completely pulled out and then inserted again
Measured: 1 day
Needle insertion time(min)
Time from pre-CT scan to the last CT scan before lung biopsy
Measured: 1 day
Procedure time(min)
Time from pre-CT scan to dressing after lung biopsy
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2017
- Study startNov 2017 (estimated)
- Primary completionJun 2019 (estimated)
- Study completionJun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Percutaneous Pulmonary Nodule BiopsyStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 106 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hyung Jin Won
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hyung Jin Won, Asan Medical Center
- Investigators
- Hyung Jin Won, MD., PhD, Principal investigator, Asan Medical Center, Seoul, Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03321994
- Sponsor's protocol ID
- AS-NPR-03
- Status last verified
- Oct 2017
- First submitted
- 23 Oct 2017
- Last updated
- 26 Oct 2017
- 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 26 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center, Randomized, Active-controlled and Evaluator-blind Investigator-initiated Trial to Evaluate and Compare the Efficacy and Safety of CT-guided Needle Guidance Using Stereotaxic Unit, Navigation Versus Conventional Biopsy Technique for the Patients Scheduled to Undergo Percutaneous Pulmonary Nodule Biopsy
- ClinicalTrials.gov ID
- NCT03321994
- Acronym / sponsor ID
- AS-NPR-03
- Conditions
- Percutaneous Pulmonary Nodule Biopsy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 106 participants (estimated)
- Lead sponsor
- Hyung Jin WonUniversity, hospital or other
- Study start
- Nov 2017 (estimated)
- Primary completion
- Jun 2019 (estimated)
- Study completion
- Jun 2019 (estimated)
- First posted
- 26 Oct 2017 (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 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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stereotaxic unit, navigation | Experimental | Device: stereotaxic unit, navigation |
| Conventional biopsy technique | Active comparator | Device: conventional biopsy technique |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (9 listed)
- 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
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 |
|---|---|---|
| stereotaxic unit, navigationCT-guided needle guidance using stereotaxic unit, navigation | Device | Stereotaxic unit, navigation |
| conventional biopsy techniqueCT-guided needle guidance using conventional biopsy technique | Device | Conventional biopsy technique |
Primary outcome
Needle guide accuracy(mm)
Time frame: 1 day
3D distance between target point and actual needle tip
5 secondary outcomes
Needle guide angle deviation(°)
Time frame: 1 day
Number of needle readjustments
Time frame: 1 day
Number of needle reinsertion
Time frame: 1 day
Needle insertion time(min)
Time frame: 1 day
Procedure time(min)
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2017.
Related trials for Percutaneous Pulmonary Nodule Biopsy
RecruitingPhase 4
A Randomized Controlled Trial Comparing Percutaneous CT-Guided Biopsy and Shape-Sensing Robotic-Assisted Bronchoscopy
Lung Cancer (Diagnosis), Lung Nodule
Not yet recruiting
The Percutaneous Interventional Surgery Control System for Pulmonary Nodule Biopsy
Pulmonary Nodules, Lung Cancer (Diagnosis)
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.
Hyung Jin Won, MD., PhD principal investigator
Asan Medical Center, Seoul, Korea
Questions about this trial
What is this clinical trial studying?
A study testing stereotaxic unit, navigation and conventional biopsy technique in people with Percutaneous Pulmonary Nodule Biopsy, run by Hyung Jin Won.
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 9 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 26 Oct 2017. 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 Hyung Jin Won, MD., PhD (82-2-3010-4352, hyungjin.won@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Needle guide accuracy(mm) (time frame: 1 day). 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 26 Oct 2017.