Bronchoscopic BiopsyNCT07653945
Red Dichromatic Imaging for Improving Post-Biopsy Bronchoscopic Field Visibility
An observational study of Bronchoscopic Biopsy and Airway Lesion, run by First Affiliated Hospital of Ningbo University at 7 sites in China.
Trial summary
The goal of this observational study is to learn whether red dichromatic imaging (RDI) can help doctors see the bronchoscopic field more clearly after a biopsy. The study will include adults who need a bronchoscopic biopsy because doctors can see an abnormal area inside the airway.During a bronchoscopic biopsy… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bronchoscopic Biopsy, Airway Lesion, Biopsy-related Bleeding
- What is being tested?
- Red Dichromatic Imaging (RDI)
- Type of treatment
- Medical device
- How many people
- 206 participants
- Where
- 7 sitesChina
- Study dates
- 1 Jul 2026to 31 Dec 2026
- How long will I take part?
- 6 Months
- 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: The study population will include adults aged 18 years or older who are scheduled to undergo clinically indicated bronchoscopic biopsy at participating centers. Eligible participants will have visible airway lesions during bronchoscopy, such as endobronchial masses, mucosal abnormalities, airway stenosis, or other abnormalities that require biopsy to determine the diagnosis. The study will not include healthy volunteers. Bronchoscopy and biopsy will be performed as part of routine clinical care, and paired white light imaging and red dichromatic imaging images will be collected during the same procedure after the first biopsy.
Who may be able to join
- Age ≥18 years.
- Visible abnormal endobronchial lesion under bronchoscopy, including endobronchial neoplasm, mucosal abnormality, airway stenosis, or other lesion requiring biopsy to determine its nature.
- Provision of informed consent to participate in this clinical study and signing of the informed consent form.
Who cannot join
- Presence of contraindications to bronchoscopy, such as severe cardiopulmonary disease, coagulation dysfunction (including patients receiving anticoagulant therapy and/or anticoagulant drugs who have not discontinued these drugs for more than 5 days before the examination), poor tolerance of anesthesia, psychiatric disease, or severe neurosis.
- Intra-procedural decrease in SpO₂ or inability to tolerate bronchoscopy.
- Obvious airway bleeding observed during bronchoscopy that may increase the risk of worsening the patient's condition.
- Images that are obviously blurred or out of focus, or that contain severe reflection, bubbles, or instrument obstruction, making subsequent image analysis impossible.
- Inability to cooperate with the study for any reason, or any other condition that the investigator considers unsuitable for study participation.
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
China7 sites
Anhui Chest Hospital
Hefei, Hefei, 230022
Fei Tang, +86-13505696936, tangfei1205@163.com
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, 200030
Ying Li, +86-15821959854, myliying@123.com
Huzhou Central Hospital
Zhejiang, Huzhou, 313000
Jiayou Luo, +86-13757071890, zhewenfu0647@163.com
The Second Hospital of Jiaxing
Zhejiang, Jiaxing, 314000
Na Li, +86-18858334316, doctorlina@126.com
Lanxi Hospital of Traditional Chinese Medicine
Zhejiang, Jinhua, 321100
Xin Shi, +86-15356893371, 121354634@qq.com
The First Affiliated Hospital of Ningbo University
Zhejiang, Ningbo, 315000
Zhongbo Chen, +86-13777125910, leonczb@163.com
Zhoushan Hospital
Zhejiang, Zhoushan, 316000
Haifeng Li, +86-13666589830, 1770182534@qq.com
About this study
The goal of this observational study is to learn whether red dichromatic imaging (RDI) can help doctors see the bronchoscopic field more clearly after a biopsy. The study will include adults who need a bronchoscopic biopsy because doctors can see an abnormal area inside the airway.During a bronchoscopic biopsy, bleeding can happen after tissue is taken. Blood may cover the biopsy area and make it harder for doctors to see where to continue the procedure.
RDI is an imaging mode that uses special colors of light to help show blood-covered areas more clearly.The main question this study aims to answer is:Does RDI improve visibility of the bronchoscopic field after bleeding caused by bronchoscopic biopsy? Researchers will compare images taken with standard white light imaging and RDI during the same bronchoscopy procedure. Both types of images will be taken after the first biopsy and before any field-clearing treatment is done.
Participants will have bronchoscopic biopsy as part of their regular medical care, have images taken using standard white light imaging and RDI during the same procedure, have routine follow-up for possible medical problems after bronchoscopy. Taking part in this study will not add extra biopsies or change the participant's regular medical care.
- Conditions
- Bronchoscopic Biopsy, Airway Lesion, Biopsy-related Bleeding
- Being tested
- Red Dichromatic Imaging (RDI)
- Keywords
- Bronchoscopy, Biopsy, Hemorrhage, Optical Imaging
- Medical subject headings
- Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Red Dichromatic Imaging (RDI)Device
Red dichromatic imaging (RDI) is an optical imaging mode used during bronchoscopy. In this observational study, RDI images and standard white light imaging images will be collected during the same clinically indicated bronchoscopy procedure after the biopsy. RDI will be evaluated for its ability to improve post-biopsy bronchoscopic field visibility. The study will not assign participants to treatment groups, add extra biopsies, or change routine clinical care.
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of post-biopsy bronchoscopic fields judged suitable for direct procedural continuation
Paired white light imaging and red dichromatic imaging images will be assessed by independent evaluators. A bronchoscopic field will be judged suitable for direct procedural continuation if the biopsy site, lesion surface, or lesion boundary remains identifiable and biopsy or subsequent bronchoscopic procedures can continue without additional field-clearing intervention.
Measured: Periprocedural
Secondary outcomes (2)
Visual distinguishability score between the bleeding area and surrounding blood-covered background
Paired white light imaging and red dichromatic imaging images will be assessed by independent evaluators. The visual distinguishability between the biopsy-related bleeding area and the surrounding blood-covered background will be scored on a 4-point scale. A score of 1 indicates that the two areas are almost indistinguishable, and a score of 4 indicates that the two areas are clearly distinguishable and easy to identify.
Measured: Periprocedural
Objective color difference between the bleeding area and surrounding blood-covered background
Objective color difference will be measured using paired white light imaging and red dichromatic imaging images. Regions of interest will be selected from the biopsy-related bleeding area and the surrounding blood-covered background. Color parameters will be measured in the CIE 1976 L*a*b* color space, and the overall color difference will be calculated as ΔE. Differences in the L*, a*, and b* channels may also be analyzed.
Measured: Periprocedural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2026
- Study start1 Jul 2026 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bronchoscopic BiopsyStudies of the same condition, open and under way.
- 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
- Prospective
- Enrolment
- 206 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Ningbo University
- Sponsor type
- Research network
- Collaborators
- Shanghai Chest Hospital, Anhui Chest Hospital, Huzhou Central Hospital, The Second Affiliated Hospital of Jiaxing University, Lanxi Hospital of Traditional Chinese Medicine, Zhoushan Hospital of Zhejiang
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07653945
- Sponsor's protocol ID
- 2026-R2021-01
- Status last verified
- Jun 2026
- First submitted
- 10 Jun 2026
- Last updated
- 17 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Red Dichromatic Imaging for Improving Post-Biopsy Bronchoscopic Field Visibility
- ClinicalTrials.gov ID
- NCT07653945
- Acronym / sponsor ID
- 2026-R2021-01
- Conditions
- Bronchoscopic Biopsy, Airway Lesion, Biopsy-related Bleeding
- Keywords
- Bronchoscopy, Biopsy, Hemorrhage, Optical Imaging
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 206 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Ningbo UniversityResearch network
- Collaborators
- Shanghai Chest Hospital, Anhui Chest Hospital, Huzhou Central Hospital, The Second Affiliated Hospital of Jiaxing University, Lanxi Hospital of Traditional Chinese Medicine, Zhoushan Hospital of Zhejiang
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 17 Jun 2026 (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.
The goal of this observational study is to learn whether red dichromatic imaging (RDI) can help doctors see the bronchoscopic field more clearly after a biopsy. The study will include adults who need a bronchoscopic biopsy because doctors can see an abnormal area inside the airway.During a bronchoscopic biopsy, bleeding can happen after tissue is taken. Blood may cover the biopsy area and make it harder for doctors to see where to continue the procedure.
RDI is an imaging mode that uses special colors of light to help show blood-covered areas more clearly.The main question this study aims to answer is:Does RDI improve visibility of the bronchoscopic field after bleeding caused by bronchoscopic biopsy? Researchers will compare images taken with standard white light imaging and RDI during the same bronchoscopy procedure. Both types of images will be taken after the first biopsy and before any field-clearing treatment is done.
Participants will have bronchoscopic biopsy as part of their regular medical care, have images taken using standard white light imaging and RDI during the same procedure, have routine follow-up for possible medical problems after bronchoscopy. Taking part in this study will not add extra biopsies or change the participant's regular medical care.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will include adults aged 18 years or older who are scheduled to undergo clinically indicated bronchoscopic biopsy at participating centers. Eligible participants will have visible airway lesions during bronchoscopy, such as endobronchial masses, mucosal abnormalities, airway stenosis, or other abnormalities that require biopsy to determine the diagnosis. The study will not include healthy volunteers. Bronchoscopy and biopsy will be performed as part of routine clinical care, and paired white light imaging and red dichromatic imaging images will be collected during the same procedure after the first biopsy.
Key inclusion criteria (3 listed)
- Age ≥18 years.
- Visible abnormal endobronchial lesion under bronchoscopy, including endobronchial neoplasm, mucosal abnormality, airway stenosis, or other lesion requiring biopsy to determine its nature.
- Provision of informed consent to participate in this clinical study and signing of the informed consent form.
Key exclusion criteria (5 listed)
- Presence of contraindications to bronchoscopy, such as severe cardiopulmonary disease, coagulation dysfunction (including patients receiving anticoagulant therapy and/or anticoagulant drugs who have not discontinued these drugs for more than 5 days before the examination), poor tolerance of anesthesia, psychiatric disease, or severe neurosis.
- Intra-procedural decrease in SpO₂ or inability to tolerate bronchoscopy.
- Obvious airway bleeding observed during bronchoscopy that may increase the risk of worsening the patient's condition.
- Images that are obviously blurred or out of focus, or that contain severe reflection, bubbles, or instrument obstruction, making subsequent image analysis impossible.
- Inability to cooperate with the study for any reason, or any other condition that the investigator considers unsuitable for study participation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Red Dichromatic Imaging (RDI)Red dichromatic imaging (RDI) is an optical imaging mode used during bronchoscopy. In this observational study, RDI images and standard white light imaging images will be collected during the same clinically indicated bronchoscopy procedure after the biopsy. RDI will be evaluated for its ability to improve post-biopsy bronchoscopic field visibility. The study will not assign participants to treatment groups, add extra biopsies, or change routine clinical care. | Device | – |
Primary outcome
Proportion of post-biopsy bronchoscopic fields judged suitable for direct procedural continuation
Time frame: Periprocedural
Paired white light imaging and red dichromatic imaging images will be assessed by independent evaluators. A bronchoscopic field will be judged suitable for direct procedural continuation if the biopsy site, lesion surface, or lesion boundary remains identifiable and biopsy or subsequent bronchoscopic procedures can continue without additional field-clearing intervention.
2 secondary outcomes
Visual distinguishability score between the bleeding area and surrounding blood-covered background
Time frame: Periprocedural
Objective color difference between the bleeding area and surrounding blood-covered background
Time frame: Periprocedural
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 17 Jun 2026.
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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.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bronchoscopic Biopsy and Airway Lesion, run by First Affiliated Hospital of Ningbo University at 7 sites 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 3 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: opening soon, as of the sponsor's last update on 17 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites 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?
Contact Zhongbo Chen (86+13777125910, leonczb@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of post-biopsy bronchoscopic fields judged suitable for direct procedural continuation (time frame: Periprocedural). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Jun 2026.