Tracheal DiseaseNCT07036614
The Novel Special Light for Endotracheal/Bronchial Lesions.
An observational study of Tracheal Disease and Bronchial Disease, run by Shanghai Chest Hospital at 1 site in China.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tracheal Disease, Bronchial Disease
- How many people
- 400 participants
- Where
- 1 siteChina
- Study dates
- 31 Jan 2024to 30 Sep 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with endotracheal/bronchial lesions scheduled for a bronschoscopy.
Who may be able to join
- Age ≥18 years old;
- Patients with chest imaging findings indicating central lung lesions requiring further bronchoscopy;
- Patients with neoplasm in the lumen that could be biopsied by bronchoscopy or operated;
- Patient who has good compliance and sign informed consent;
- 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.
Who cannot join
- Pregnant or lactating women;
- No endotracheal/bronchial lesions were detected by bronchoscopy;
- Allergic reaction to narcotic drugs in previous medical history;
- The investigator believes that the subject is not suitable for bronchoscopy;
- High-risk diseases or other special conditions for which the investigator considers the subjects unsuitable for clinical trials.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The Application of Novel Special Light in the Diagnosis of Endotracheal/Bronchial Lesions.
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.
- Conditions
- Tracheal Disease, Bronchial Disease
- Keywords
- TXI, NBI, RDI, WLI
- Medical subject headings
- Tracheal Diseases, Bronchial Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2025
- Study start31 Jan 2024
- Primary completion30 Sep 2025 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Tracheal DiseaseStudies of the same condition, open and under way.
- More trials run by Shanghai Chest HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Chest Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jiayuan Sun, Shanghai Chest Hospital
- Investigators
- Jiayuan Sun, MD, PhD, Study director, Shanghai Chest Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07036614
- Sponsor's protocol ID
- SHCHE202409
- Status last verified
- Jan 2025
- First submitted
- 17 Jun 2025
- Last updated
- 25 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Investigators may release the database after the study, but no decision has been made yet.
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 31912902Chen 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
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Application of Novel Special Light in the Diagnosis of Endotracheal/Bronchial Lesions.
- ClinicalTrials.gov ID
- NCT07036614
- Acronym / sponsor ID
- SHCHE202409
- Conditions
- Tracheal Disease, Bronchial Disease
- Keywords
- TXI, NBI, RDI, WLI
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Shanghai Chest HospitalUniversity, hospital or other
- Study start
- 31 Jan 2024 (actual)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 25 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with endotracheal/bronchial lesions scheduled for a bronschoscopy.
Key inclusion criteria (5 listed)
- Age ≥18 years old;
- Patients with chest imaging findings indicating central lung lesions requiring further bronchoscopy;
- Patients with neoplasm in the lumen that could be biopsied by bronchoscopy or operated;
- Patient who has good compliance and sign informed consent;
- 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.
Key exclusion criteria (5 listed)
- Pregnant or lactating women;
- No endotracheal/bronchial lesions were detected by bronchoscopy;
- Allergic reaction to narcotic drugs in previous medical history;
- The investigator believes that the subject is not suitable for bronchoscopy;
- High-risk diseases or other special conditions for which the investigator considers the subjects unsuitable for clinical trials.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Diagnostic accuracy of the special light for endotracheal/bronchial Lesions.
Time frame: 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.
1 secondary outcome
The diagnostic methods and grading criteria of the special light
Time frame: 1 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2025.
- Background: PubMed 31912902Siegel 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.
- Background: PubMed 26808342Chen 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.
- Individual participant dataSharing planned: Undecided. Investigators may release the database after the study, but no decision has been made yet.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jiayuan Sun, MD, PhD study director
Shanghai Chest Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tracheal Disease and Bronchial Disease, run by Shanghai Chest Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 25 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic accuracy of the special light for endotracheal/bronchial Lesions. (time frame: 1month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07036614, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2025.