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Starting soon Observational

Red Dichromatic Imaging for Improving Post-Biopsy Bronchoscopic Field Visibility

NCT07653945 · tracked via the Priya Life Science China tracker
Phase
Observational
Started
2026-07-01
Last updated
2026-06-17

Condition(s) studied

Bronchoscopic BiopsyAirway LesionBiopsy-related Bleeding

Investigational drug(s) / intervention(s)

Red Dichromatic Imaging (RDI)

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.

Study 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, 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: 1. Age ≥18 years. 2. Visible abnormal endobronchial lesion under bronchoscopy, including endobronchial neoplasm, mucosal abnormality, airway stenosis, or other lesion requiring biopsy to determine its nature. 3. Provision of informed consent to participate in this clinical study and signing of the informed consent form. Exclusion Criteria: 1. 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. 2. Intra-procedural decrease in SpO₂ or inability to tolerate bronchoscopy. 3. Obvious airway bleeding observed during bronchoscopy that may increase the risk of worsening the patient's condition. 4. Images that are obviously blurred or out of focus, or that contain severe reflection, bubbles, or instrument obstruction, making subsequent image analysis impossible. 5. Inability to cooperate with the study for any reason, or any other condition that the investigator considers unsuitable for study participation.

Primary outcome measure(s)

  • Proportion of post-biopsy bronchoscopic fields judged suitable for direct procedural continuation — 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.

Trial sites (7)

FacilityCityRegionStatus
Anhui Chest Hospital Hefei Hefei
Huzhou Central Hospital Zhejiang Huzhou
The Second Hospital of Jiaxing Zhejiang Jiaxing
Lanxi Hospital of Traditional Chinese Medicine Zhejiang Jinhua
The First Affiliated Hospital of Ningbo University Zhejiang Ningbo
Shanghai Chest Hospital Shanghai Shanghai Municipality
Zhoushan Hospital Zhejiang Zhoushan
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07653945 on ClinicalTrials.gov ↗ ← All trials in China