Red Dichromatic Imaging for Improving Post-Biopsy Bronchoscopic Field Visibility

ClinicalTrials.gov ID

NCT07653945

Lead Sponsor

First Affiliated Hospital of Ningbo UniversityNETWORK

Overall Status

Not yet recruiting

Study Type

Observational

Enrollment

206Estimated

Last Update Posted

Jun 17, 2026Actual

Start Date

Jul 1, 2026Estimated

Primary Completion Date

Dec 31, 2026Estimated

Completion Date

Dec 31, 2026Estimated

Official Title

Red Dichromatic Imaging for Improving Post-Biopsy Bronchoscopic Field Visibility

Brief 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.

• Bronchoscopic Biopsy
• Airway Lesion
• Biopsy-related Bleeding

• Red Dichromatic Imaging (RDI)

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

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.

Observational Model

Cohort

Time Perspective

Prospective

Lead Sponsor

First Affiliated Hospital of Ningbo UniversityNETWORK

Collaborators

Shanghai Chest HospitalOTHER

Anhui Chest HospitalOTHER

Huzhou Central HospitalOTHER

The Second Affiliated Hospital of Jiaxing UniversityOTHER

Lanxi Hospital of Traditional Chinese MedicineOTHER

Zhoushan Hospital of ZhejiangUNKNOWN

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