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Lung NeoplasmsNCT04447482

ENB Vs. Conventional Bronchoscopy With Fluoroscopy for Safe and Effective Biopsy of Pulmonary Lesions

A study testing ENB with image-guided lung biopsy and Conventional Bronchoscopy guided by Fluoroscopy in people with Lung Neoplasms and Pulmonary Neoplasm, run by Shanghai Youhe Medical Technology Co., Ltd. at 4 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Evaluate results for participants with lung lesions randomized to either 4D Electromagnetic Navigation Bronchoscopy (4D-ENB) versus Conventional Bronchoscopy with Fluoroscopy for diagnostic biopsy and detection of lung cancer. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Lung Neoplasms, Pulmonary Neoplasm
What is being tested?
ENB with image-guided lung biopsy and Conventional Bronchoscopy guided by Fluoroscopy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
212 participants
Where
4 sitesChina
Study dates
10 Jul 2020to 30 Sep 2021
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 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subjects must meet all of the following criteria to be selected:
  • Be older than 18 (including 18) and younger than 75 (including 75);
  • The population with peripheral lung lesions detected in chest CT scanning and who require biopsy;
  • The subjects are willing to undergo bronchoscopy and meet the requirements for bronchoscopy;
  • The subjects or their guardians can understand the trial objective, volunteer to participate and sign the informed consent form.

Who cannot join

  • Subjects will be excluded if they meet any of the following criteria:
  • The patient is participating in another drug or medical device clinical trial (drug clinical trial within 3 months or medical device clinical trial within 1 month);
  • Women of childbearing age who have positive pregnancy test result and lactating women;
  • Allergic to anesthetics;
  • Bronchoscopy contraindications, including: active massive hemoptysis; recent myocardial infarction or unstable angina pectoris; severe heart and lung dysfunction; severe hypertension and arrhythmia; uncorrectable bleeding tendency (such as severe coagulation disorders, uremia and severe pulmonary hypertension); severe superior vena cava obstruction syndrome; suspected aortic aneurysm; multiple pulmonary bullae; systemically extreme exhaustion.
  • Visible intraluminal lesions found during bronchoscopy;
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  • Patients with severe lung diseases (including: severe bronchodilatation, severe emphysema, etc.) and patients determined to be unsuitable for the examination by the investigators;
  • Patients with a pacemaker or defibrillator;
  • Patients who cannot cooperate with the doctor to complete bronchoscopy, such as patients with mental and neurological diseases, mental retardation and mental disorders;
  • Patients to whom bronchoscopy and bronchoscopic sampling are not applicable to diagnose the lesions, or other patients determined to be unsuitable for this trial by the investigators.

Trial locations and contacts

4 sites in 1 country.

Cathaly Hong contact

8613524168379

cathaly_hong@163.com

China4 sites, 4 recruiting

  • The First Affiliated Hospital, Zhejiang University School of Medicine

    Hanzhou, Zhejiang

    Hu Jian, MD

    Hu Jian, MD

    Recruiting

  • Shanghai Changhai Hospital

    Shanghai

    Bai Chong, MD

    Bai Chong, MD

    Recruiting

  • Shanghai Chest Hospital

    Shanghai

    Sun Jiayuan, MD

    Sun Jiayuan, MD

    Recruiting

  • Shanghai East Hospital

    Shanghai

    Li Qiang, MD

    Li Qiang, MD

    Recruiting

Other trials in China

About this study

Official title: A Prospective, Randomized, Multi-center, Superiority Clinical Study to Evaluate the Effectiveness and Safety of Bronchoscopic Lung Biopsy Under the Guide of CT Stereotactic Auxiliary Equipment and Accessories

Evaluate results for participants with lung lesions randomized to either 4D Electromagnetic Navigation Bronchoscopy (4D-ENB) versus Conventional Bronchoscopy with Fluoroscopy for diagnostic biopsy and detection of lung cancer.

Read the detailed description

The objective of this clinical trial is to evaluate the safety and efficacy results for two bronchoscopic biopsy techniques for sampling lung lesions: either image-guided electromagnetic navigation or conventional bronchoscopy with fluoroscopy. The diagnostic yield and adverse events of participants prospectively randomized to either arm will be evaluated. This is a prospective, randomized, multi-center study.

Being tested
ENB with image-guided lung biopsy, Conventional Bronchoscopy guided by Fluoroscopy
Keywords
Peripheral Pulmonary Lesion, Lung Biopsy, Electromagnetic Navigation Bronchoscopy, Bronchoscopy, Fluoroscopy
Medical subject headings
Lung Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ENB with image-guided lung biopsyDevice

    Also called SPiN Thoracic Navigation System™

    Electromagnetic navigational bronchoscopy system with tip tracked instruments.

  • Conventional Bronchoscopy guided by FluoroscopyProcedure or surgery

    Bronchoscopic lung biopsy with fluoroscopy.

Study groups in NCT04447482
Study groupRoleWhat they receive
Treatment GroupExperimental4D electromagnetic navigation bronchoscopy (4D-ENB) for lung biopsy. Guidance based on tip tracked surgical tools and images calculated from CT.
Receives: Device: ENB with image-guided lung biopsy
Control GroupActive comparatorBronchoscopic lung biopsy taken while using X-ray fluoroscopy.
Receives: Procedure: Conventional Bronchoscopy guided by Fluoroscopy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Evaluate the diagnostic rate of lung biopsies between the treatment group and the control group.

    Diagnostic rate is defined as the proportion of true positive and true negative.

    Measured: 6 months.

Secondary outcomes (5)

  1. Sampling success rate of the treatment group and the control group.

    Sampling success rate means the proportion of lung nodules and abnormal lung tissues in all tissues sampled from bronchoscopic lung biopsy.

    Measured: 2 weeks.

  2. Navigation time (time to find the lesions) of the treatment group and the control group.

    For this outcome, duration of procedure is defined as the time from the biopsy tool reaching the main carina (registration) to the biopsy tool reaching the lesion.

    Measured: Duration of procedure, or up to 120 minutes.

  3. Total operation time of the treatment group and the control group.

    For this outcome, duration of procedure is defined as the time from the bronchoscopy accessing the glottis for the first time to bronchoscopy exiting the glottis for the last time.

    Measured: Duration of procedure, or up to 120 minutes.

  4. Navigation success rate of 4D-ENB and biopsy accessories.

    Navigation success rate is defined as the proportion of the biopsy tools reaching the lung tissues. For this outcome, duration of procedure is defined as the time from the biopsy tool reaching the main carina (registration) to finishing the biopsy for the last time.

    Measured: Duration of procedure, or up to 120 minutes.

  5. Device performance evaluation of CT Stereotactic Auxiliary Equipment and Accessories.

    Device performance means the functions, reliability, safety and accessibility of the system. Performance will be evaluated by observing these characteristics during the procedure. For this outcome, duration of procedure is defined as the time from the biopsy tool reaching the main carina (registration) to finishing the biopsy for the last time.

    Measured: Duration of procedure, or up to 120 minutes.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jun 2020
  2. Study start10 Jul 2020
  3. Primary completion30 Jun 2021 (estimated)
  4. Study completion30 Sep 2021 (estimated)

Resources

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
Diagnosis
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
212 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04447482
Sponsor's protocol ID
202001131102-CT
Status last verified
Mar 2021
First submitted
8 May 2020
Last updated
18 Mar 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes

Publications

  • Raval AA, Amir L. Community hospital experience using electromagnetic navigation bronchoscopy system integrating tidal volume computed tomography mapping. Lung Cancer Manag. 2016 Apr;5(1):9-19. doi: 10.2217/lmt-2015-0007. Epub 2016 Apr 8.

    PubMed 30643545

  • Flenaugh, E.L., & Mohammed, K.H.. Initial Experience Using 4D Electromagnetic Navigation Bronchoscopy System With Tip Tracked Instruments For Localization of Peripheral Lung Nodules. The Internet Journal of Pulmonary Medicine 18(1): 1-7, 2016.

Questions about this trial

What is this clinical trial studying?

A study testing ENB with image-guided lung biopsy and Conventional Bronchoscopy guided by Fluoroscopy in people with Lung Neoplasms and Pulmonary Neoplasm, run by Shanghai Youhe Medical Technology Co., Ltd. at 4 sites in China.

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 5 inclusion and 10 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 18 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

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 Cathaly Hong (8613524168379, cathaly_hong@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Evaluate the diagnostic rate of lung biopsies between the treatment group and the control group. (time frame: 6 months.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04447482, which also lists 2 linked publications.

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 18 Mar 2021.

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