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Not yet recruiting NCT07653945

Red Dichromatic Imaging for Improving Post-Biopsy Bronchoscopic Field Visibility

— Observational Bronchoscopic Biopsy Airway Lesion Biopsy-related Bleeding

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Red Dichromatic Imaging (RDI).
Who it may be relevant to
Registry conditions: Bronchoscopic Biopsy, Airway Lesion, Biopsy-related Bleeding. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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.

Interventions

  • Device 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.

Primary outcome measures

  • Proportion of post-biopsy bronchoscopic fields judged suitable for direct procedural continuation [Time frame: Periprocedural]
Secondary outcome measures (2)
  • 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]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

China · 7 centers
  • Anhui Chest Hospital — Hefei
  • Huzhou Central Hospital — Zhejiang
  • The Second Hospital of Jiaxing — Zhejiang
  • Lanxi Hospital of Traditional Chinese Medicine — Zhejiang
  • The First Affiliated Hospital of Ningbo University — Zhejiang
  • Shanghai Chest Hospital — Shanghai
  • Zhoushan Hospital — Zhejiang

Identifiers

NCT: NCT07653945 · 2026-R2021-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗