Red Dichromatic Imaging for Improving Post-Biopsy Bronchoscopic Field Visibility

NCT07653945 | Not Yet Recruiting

• 1 other identifier: 2026-R2021-01
• Study Type: observational
• Target: 206
• Locations: 1 country
• Sites: 7

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.

Conditions

Bronchoscopic Biopsy; Airway Lesion; Biopsy-related Bleeding

Keywords

Bronchoscopy; Biopsy; Hemorrhage; Optical Imaging

Outcome Measures

Primary Outcomes (1)

• 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.

  Periprocedural

Secondary Outcomes (2)

• Visual distinguishability score between the bleeding area and surrounding blood-covered background

  Periprocedural

• Objective color difference between the bleeding area and surrounding blood-covered background

  Periprocedural

Other Outcomes (1)

• Proportion of bronchoscopic fields judged suitable for procedural continuation after one field-clearing intervention

  Periprocedural

Interventions

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• First Affiliated Hospital of Ningbo University: lead
• Shanghai Chest Hospital: collaborator
• Anhui Chest Hospital: collaborator
• Huzhou Central Hospital: collaborator
• The Second Affiliated Hospital of Jiaxing University: collaborator
• Lanxi Hospital of Traditional Chinese Medicine: collaborator
• Zhoushan Hospital of Zhejiang: collaborator

Study Sites (7)

Anhui Chest Hospital

Hefei, Hefei, 230022, China

Location

Huzhou Central Hospital

Zhejiang, Huzhou, 313000, China

Location

The Second Hospital of Jiaxing

Zhejiang, Jiaxing, 314000, China

Location

Lanxi Hospital of Traditional Chinese Medicine

Zhejiang, Jinhua, 321100, China

Location

The First Affiliated Hospital of Ningbo University

Zhejiang, Ningbo, 315000, China

Location

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, 200030, China

Location

Zhoushan Hospital

Zhejiang, Zhoushan, 316000, China

Location

MeSH Terms

Conditions

Hemorrhage

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Zhongbo Chen

CONTACT

86+13777125910; leonczb@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2026
• First Posted: June 17, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: June 17, 2026

Record last verified: 2026-06

Locations

CN (7)