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

March 16, 2021 updated by: Shanghai Youhe Medical Technology Co., Ltd.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

212

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Shanghai, China
        • Recruiting
        • Shanghai Chest Hospital
        • Contact:
          • Sun Jiayuan, MD
        • Principal Investigator:
          • Sun Jiayuan, MD
      • Shanghai, China
        • Recruiting
        • Shanghai East Hospital
        • Contact:
          • Li Qiang, MD
        • Principal Investigator:
          • Li Qiang, MD
      • Shanghai, China
        • Recruiting
        • Shanghai Changhai Hospital
        • Contact:
          • Bai Chong, MD
        • Principal Investigator:
          • Bai Chong, MD
    • Zhejiang
      • Hanzhou, Zhejiang, China
        • Recruiting
        • The First Affiliated Hospital, Zhejiang University School of Medicine
        • Contact:
          • Hu Jian, MD
        • Principal Investigator:
          • Hu Jian, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subjects must meet all of the following criteria to be selected:

    1. Be older than 18 (including 18) and younger than 75 (including 75);
    2. The population with peripheral lung lesions detected in chest CT scanning and who require biopsy;
    3. The subjects are willing to undergo bronchoscopy and meet the requirements for bronchoscopy;
    4. The subjects or their guardians can understand the trial objective, volunteer to participate and sign the informed consent form.

Exclusion Criteria:

  • Subjects will be excluded if they meet any of the following criteria:

    1. 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);
    2. Women of childbearing age who have positive pregnancy test result and lactating women;
    3. Allergic to anesthetics;
    4. 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.
    5. Visible intraluminal lesions found during bronchoscopy;
    6. Patients with severe lung diseases (including: severe bronchodilatation, severe emphysema, etc.) and patients determined to be unsuitable for the examination by the investigators;
    7. Patients with a pacemaker or defibrillator;
    8. Patients who cannot cooperate with the doctor to complete bronchoscopy, such as patients with mental and neurological diseases, mental retardation and mental disorders;
    9. 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment Group
4D electromagnetic navigation bronchoscopy (4D-ENB) for lung biopsy. Guidance based on tip tracked surgical tools and images calculated from CT.
Device: ENB with image-guided lung biopsy
Electromagnetic navigational bronchoscopy system with tip tracked instruments.
Other Names:
  • SPiN Thoracic Navigation System™
Active Comparator: Control Group
Bronchoscopic lung biopsy taken while using X-ray fluoroscopy.
Procedure: Conventional Bronchoscopy guided by Fluoroscopy
Bronchoscopic lung biopsy with fluoroscopy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate the diagnostic rate of lung biopsies between the treatment group and the control group.
Time Frame: 6 months.
Diagnostic rate is defined as the proportion of true positive and true negative.
6 months.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sampling success rate of the treatment group and the control group.
Time Frame: 2 weeks.
Sampling success rate means the proportion of lung nodules and abnormal lung tissues in all tissues sampled from bronchoscopic lung biopsy.
2 weeks.
Navigation time (time to find the lesions) of the treatment group and the control group.
Time Frame: Duration of procedure, or up to 120 minutes.
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.
Duration of procedure, or up to 120 minutes.
Total operation time of the treatment group and the control group.
Time Frame: Duration of procedure, or up to 120 minutes.
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.
Duration of procedure, or up to 120 minutes.
Navigation success rate of 4D-ENB and biopsy accessories.
Time Frame: Duration of procedure, or up to 120 minutes.
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.
Duration of procedure, or up to 120 minutes.
Device performance evaluation of CT Stereotactic Auxiliary Equipment and Accessories.
Time Frame: Duration of procedure, or up to 120 minutes.
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.
Duration of procedure, or up to 120 minutes.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Youhe Medical Technology Co., Ltd.

Investigators

  • Study Director: Cathaly Hong, Shanghai Youhe Medical Technology Co., Ltd.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 10, 2020

Primary Completion (Anticipated)

June 30, 2021

Study Completion (Anticipated)

September 30, 2021

Study Registration Dates

First Submitted

May 8, 2020

First Submitted That Met QC Criteria

June 23, 2020

First Posted (Actual)

June 25, 2020

Study Record Updates

Last Update Posted (Actual)

March 18, 2021

Last Update Submitted That Met QC Criteria

March 16, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202001131102-CT

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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