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
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.
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.
33 studies on the registry are indexed under Tracheal Diseases; 7 are open to participants now.
This study's planned enrollment of 400 is above the median of 288 across 10 observational studies indexed under Tracheal Diseases.
Browse Tracheal Diseases studies →Shanghai Chest Hospital is the lead sponsor of 198 studies on the registry; 98 are open to participants now.
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Patients with endotracheal/bronchial lesions scheduled for a bronschoscopy.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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
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
Plan to share: Undecided — Investigators may release the database after the study, but no decision has been made yet.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
No contact was published for this record. The registry link below has the sponsor’s details.
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