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

NCT04447482 | Unknown DMC FDA Device

• 1 other identifier: 202001131102-CT
• Study Type: interventional
• Target: 212
• Locations: 1 country
• Sites: 4

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.

Conditions

Lung Neoplasms; Pulmonary Neoplasm

Keywords

Peripheral Pulmonary Lesion; Lung Biopsy; Electromagnetic Navigation Bronchoscopy; Bronchoscopy; Fluoroscopy

Outcome Measures

Primary Outcomes (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.

  6 months.

Secondary Outcomes (5)

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

  2 weeks.

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

  Duration of procedure, or up to 120 minutes.

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

  Duration of procedure, or up to 120 minutes.

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

  Duration of procedure, or up to 120 minutes.

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

  Duration of procedure, or up to 120 minutes.

Study Arms (2)

Treatment Group

EXPERIMENTAL

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

Control Group

ACTIVE COMPARATOR

Bronchoscopic lung biopsy taken while using X-ray fluoroscopy.

Procedure: Conventional Bronchoscopy guided by Fluoroscopy

Interventions

ENB with image-guided lung biopsy DEVICE

Electromagnetic navigational bronchoscopy system with tip tracked instruments.

Also known as: SPiN Thoracic Navigation System™

Treatment Group

Conventional Bronchoscopy guided by Fluoroscopy PROCEDURE

Bronchoscopic lung biopsy with fluoroscopy.

Control Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Youhe Medical Technology Co., Ltd.: lead

Study Sites (4)

The First Affiliated Hospital, Zhejiang University School of Medicine

Hanzhou, Zhejiang, China

RECRUITING

Shanghai Changhai Hospital

Shanghai, China

RECRUITING

Shanghai Chest Hospital

Shanghai, China

RECRUITING

Shanghai East Hospital

Shanghai, China

RECRUITING

Related Publications (2)

• 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.

  PMID: 30643545 BACKGROUND

• 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.

  BACKGROUND

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Cathaly Hong

  Shanghai Youhe Medical Technology Co., Ltd.

  STUDY DIRECTOR

Central Study Contacts

Cathaly Hong

CONTACT

8613524168379; cathaly_hong@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2020
• First Posted: June 25, 2020
• Study Start: July 10, 2020
• Primary Completion: June 30, 2021
• Study Completion: September 30, 2021
• Last Updated: March 18, 2021

Record last verified: 2021-03

Locations

CN (4)