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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

212 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-10

Study Completion Date

2021-09-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Lung Neoplasms Pulmonary Neoplasm

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Treatment Group

4D electromagnetic navigation bronchoscopy (4D-ENB) for lung biopsy. Guidance based on tip tracked surgical tools and images calculated from CT.

Group Type EXPERIMENTAL

ENB with image-guided lung biopsy

Intervention Type DEVICE

Electromagnetic navigational bronchoscopy system with tip tracked instruments.

Control Group

Bronchoscopic lung biopsy taken while using X-ray fluoroscopy.

Group Type ACTIVE_COMPARATOR

Conventional Bronchoscopy guided by Fluoroscopy

Intervention Type PROCEDURE

Bronchoscopic lung biopsy with fluoroscopy.

Interventions

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ENB with image-guided lung biopsy

Electromagnetic navigational bronchoscopy system with tip tracked instruments.

Intervention Type DEVICE

Conventional Bronchoscopy guided by Fluoroscopy

Bronchoscopic lung biopsy with fluoroscopy.

Intervention Type PROCEDURE

Other Intervention Names

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SPiN Thoracic Navigation System™

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No