Back to resultsENB Vs. Conventional Bronchoscopy With Fluoroscopy for Safe and Effective Biopsy of Pulmonary Lesions
Primary Purpose
Lung Neoplasms, Pulmonary Neoplasm
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
ENB with image-guided lung biopsy
Conventional Bronchoscopy guided by Fluoroscopy
Sponsored by
About this trial
This is an interventional diagnostic trial for Lung Neoplasms focused on measuring Peripheral Pulmonary Lesion, Lung Biopsy, Electromagnetic Navigation Bronchoscopy, Bronchoscopy, Fluoroscopy
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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;
- 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.
Sites / Locations
- The First Affiliated Hospital, Zhejiang University School of MedicineRecruiting
- Shanghai Changhai HospitalRecruiting
- Shanghai Chest HospitalRecruiting
- Shanghai East HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Treatment Group
Control Group
Arm Description
4D electromagnetic navigation bronchoscopy (4D-ENB) for lung biopsy. Guidance based on tip tracked surgical tools and images calculated from CT.
Bronchoscopic lung biopsy taken while using X-ray fluoroscopy.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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.
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.
Full Information
NCT ID
NCT04447482
First Posted
May 8, 2020
Last Updated
March 16, 2021
Sponsor
Shanghai Youhe Medical Technology Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT04447482
Brief Title
ENB Vs. Conventional Bronchoscopy With Fluoroscopy for Safe and Effective Biopsy of Pulmonary Lesions
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Unknown status
Study Start Date
July 10, 2020 (Actual)
Primary Completion Date
June 30, 2021 (Anticipated)
Study Completion Date
September 30, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai Youhe Medical Technology Co., Ltd.
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Neoplasms, Pulmonary Neoplasm
Keywords
Peripheral Pulmonary Lesion, Lung Biopsy, Electromagnetic Navigation Bronchoscopy, Bronchoscopy, Fluoroscopy
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
212 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Treatment Group
Arm Type
Experimental
Arm Description
4D electromagnetic navigation bronchoscopy (4D-ENB) for lung biopsy. Guidance based on tip tracked surgical tools and images calculated from CT.
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
Bronchoscopic lung biopsy taken while using X-ray fluoroscopy.
Intervention Type
Device
Intervention Name(s)
ENB with image-guided lung biopsy
Other Intervention Name(s)
SPiN Thoracic Navigation System™
Intervention Description
Electromagnetic navigational bronchoscopy system with tip tracked instruments.
Intervention Type
Procedure
Intervention Name(s)
Conventional Bronchoscopy guided by Fluoroscopy
Intervention Description
Bronchoscopic lung biopsy with fluoroscopy.
Primary Outcome Measure Information:
Title
Evaluate the diagnostic rate of lung biopsies between the treatment group and the control group.
Description
Diagnostic rate is defined as the proportion of true positive and true negative.
Time Frame
6 months.
Secondary Outcome Measure Information:
Title
Sampling success rate of the treatment group and the control group.
Description
Sampling success rate means the proportion of lung nodules and abnormal lung tissues in all tissues sampled from bronchoscopic lung biopsy.
Time Frame
2 weeks.
Title
Navigation time (time to find the lesions) of the treatment group and the control group.
Description
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.
Time Frame
Duration of procedure, or up to 120 minutes.
Title
Total operation time of the treatment group and the control group.
Description
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.
Time Frame
Duration of procedure, or up to 120 minutes.
Title
Navigation success rate of 4D-ENB and biopsy accessories.
Description
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.
Time Frame
Duration of procedure, or up to 120 minutes.
Title
Device performance evaluation of CT Stereotactic Auxiliary Equipment and Accessories.
Description
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.
Time Frame
Duration of procedure, or up to 120 minutes.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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;
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cathaly Hong
Phone
8613524168379
Email
cathaly_hong@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cathaly Hong
Organizational Affiliation
Shanghai Youhe Medical Technology Co., Ltd.
Official's Role
Study Director
Facility Information:
Facility Name
The First Affiliated Hospital, Zhejiang University School of Medicine
City
Hanzhou
State/Province
Zhejiang
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hu Jian, MD
First Name & Middle Initial & Last Name & Degree
Hu Jian, MD
Facility Name
Shanghai Changhai Hospital
City
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bai Chong, MD
First Name & Middle Initial & Last Name & Degree
Bai Chong, MD
Facility Name
Shanghai Chest Hospital
City
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sun Jiayuan, MD
First Name & Middle Initial & Last Name & Degree
Sun Jiayuan, MD
Facility Name
Shanghai East Hospital
City
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Li Qiang, MD
First Name & Middle Initial & Last Name & Degree
Li Qiang, MD
12. IPD Sharing Statement
Citations:
PubMed Identifier
30643545
Citation
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.
Results Reference
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Citation
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.
Results Reference
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ENB Vs. Conventional Bronchoscopy With Fluoroscopy for Safe and Effective Biopsy of Pulmonary Lesions
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