The Novel Special Light for Endotracheal/Bronchial 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

ENROLLING_BY_INVITATION

Total Enrollment

400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-01-31

Study Completion Date

2026-09-30

Brief Summary

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This is a single-center study. The purpose of this study is o evaluate the diagnostic value of special light (TXI, NBI, RDI) in endotracheal/bronchial lesions.

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Detailed Description

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The latest endoscopic system, EVIS X1 (Olympus Medical Systems, Tokyo, Japan), was developed in 2020, which includes brighter and clearer WLI, third-generation (3G)-NBI, texture and color enhancement imaging (TXI) ,and red dichromatic imaging (RDI) as a new image-enhanced endoscopy (IEE) . texture and color enhancement imaging (TXI) as a new image-enhanced endoscopy (IEE). The TXI is designed to enhance the 3 image elements of WLI (texture, brightness, and color) using Retinex-based enhancements while maintaining image naturalness (WLI appearance) clearly defines subtle tissue differences. RDI enables observation of deeper tissue regions by utilizing light of longer wavelengths; such light has weak light scattering characteristics, thus providing the opposite effect of NBI. The original purpose of RDI was to reduce the risk of bleeding during endoscopic treatment by improving the visibility of thick blood vessels in deeper tissues. Although great efforts have been made in exploring the various clinical efficacies of RDI, no published reports have comprehensively covered both the technological and clinical aspects of RDI. The purpose of this study is o evaluate the diagnostic value of special light (TXI, NBI, RDI) in endotracheal/bronchial lesions.

Conditions

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Tracheal Disease Bronchial Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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Patients with endotracheal/bronchial lesions.

Approximately 400 patients who meet the inclusion and exclusion criteria will be enrolled to develop and validate the the Novel Special Light for the diagnosis of endotracheal/bronchial lesions.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

1. Age ≥18 years old;
2. Patients with chest imaging findings indicating central lung lesions requiring further bronchoscopy;
3. Patients with neoplasm in the lumen that could be biopsied by bronchoscopy or operated;
4. Patient who has good compliance and sign informed consent;
5. The investigator believes that the subjects can understand the process of the clinical study, are willing and able to complete all the research procedures and follow-up visits, and cooperate with the research procedures.

Exclusion Criteria

1. Pregnant or lactating women;
2. No endotracheal/bronchial lesions were detected by bronchoscopy;
3. Allergic reaction to narcotic drugs in previous medical history;
4. The investigator believes that the subject is not suitable for bronchoscopy;
5. High-risk diseases or other special conditions for which the investigator considers the subjects unsuitable for clinical trials.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No