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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
212

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Shanghai Youhe Medical Technology Co., Ltd.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 10, 2020

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2021

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 30, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 8, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 23, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 25, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 18, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 16, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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