The Novel Special Light for Endotracheal/Bronchial Lesions.

The Application of Novel Special Light in the Diagnosis of Endotracheal/Bronchial Lesions.

Status

Enrolling by invitation

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07036614

Enrollment

400

Registered

2025-06-25

Start date

2024-01-31

Completion date

2026-09-30

Last updated

2025-06-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bronchial Disease, Tracheal Disease

Keywords

TXI, NBI, RDI, WLI

Brief summary

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.

Detailed description

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

OTHER

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Diagnostic accuracy of the special light for endotracheal/bronchial Lesions.	1month	Histopathology will be used as the gold standard. To compare the diagnostic value of the special light (TXI, NBI, RDI) and white light (WLI) in differential diagnosis of benign and malignant luminal lesions.

Secondary

Measure	Time frame	Description
The diagnostic methods and grading criteria of the special light	1 month	Based on the special light (TXI, NBI, RDI), the diagnostic methods and grading criteria for benign and malignant endotracheal/bronchial lesions were established.

Countries

China

Outcome results