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Enrolling by invitationNCT07036614Updated Jun 25, 2025

The Novel Special Light for Endotracheal/Bronchial Lesions.

An observational study in Tracheal Disease and Bronchial Disease, sponsored by Shanghai Chest Hospital. Enrolling by invitation at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-06-25.

Sponsored by Shanghai Chest Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Other
Enrollment
400
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Tracheal Disease
  • Bronchial Disease

Keywords

  • TXI
  • NBI
  • RDI
  • WLI
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with endotracheal/bronchial lesions scheduled for a bronschoscopy.

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

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.
04

Study design

Observational model
Cohort
Time perspective
Other
Enrollment
400 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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.

05

What researchers measure

Primary outcomes

  1. Diagnostic accuracy of the special light for endotracheal/bronchial Lesions.

    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.

    Time frame: 1month

Secondary outcomes

  1. The diagnostic methods and grading criteria of the special light

    Based on the special light (TXI, NBI, RDI), the diagnostic methods and grading criteria for benign and malignant endotracheal/bronchial lesions were established.

    Time frame: 1 month

06

Study locations

1 site
  • Shanghai Chest Hospital
    Shanghai, Shanghai Municipality 200030, China
07

References and documents

Publications

  • Siegel RL, Miller KD, Jemal A. Cancer statistics, 2020. CA Cancer J Clin. 2020 Jan;70(1):7-30. doi: 10.3322/caac.21590. Epub 2020 Jan 8. PubMed 31912902 ↗
  • Chen W, Zheng R, Baade PD, Zhang S, Zeng H, Bray F, Jemal A, Yu XQ, He J. Cancer statistics in China, 2015. CA Cancer J Clin. 2016 Mar-Apr;66(2):115-32. doi: 10.3322/caac.21338. Epub 2016 Jan 25. PubMed 26808342 ↗

Individual participant data

Plan to share: Undecided — Investigators may release the database after the study, but no decision has been made yet.

08

Registry details

Key details

Study ID
NCT07036614
Lead sponsor
Shanghai Chest Hospital
Responsible party
Jiayuan Sun (Director, Department of Respiratory Endoscopy, Shanghai Chest Hospital) — Principal investigator
First posted
Jun 25, 2025
Start date
Jan 31, 2024
Primary completion
Sep 30, 2025 (estimated)
Completion
Sep 30, 2026 (estimated)
Last update
Jun 25, 2025

Study contacts

Jiayuan Sun, MD, PhD
study director · Shanghai Chest Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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