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Набор скоро начнётся NCT07653945

Red Dichromatic Imaging for Improving Post-Biopsy Bronchoscopic Field Visibility

— Наблюдательное Bronchoscopic Biopsy Airway Lesion Biopsy-related Bleeding

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Red Dichromatic Imaging (RDI).
Кому может быть актуально
Состояния в реестре: Bronchoscopic Biopsy, Airway Lesion, Biopsy-related Bleeding. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Китай
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

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.

Вмешательства

  • Устройство 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.

Первичные конечные точки

  • Proportion of post-biopsy bronchoscopic fields judged suitable for direct procedural continuation [Срок оценки: Periprocedural]
Вторичные конечные точки (2)
  • Visual distinguishability score between the bleeding area and surrounding blood-covered background [Срок оценки: Periprocedural]
  • Objective color difference between the bleeding area and surrounding blood-covered background [Срок оценки: Periprocedural]

Критерии участия

Критерии включения

  • 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.

Критерии исключения

  • 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Китай · 7 центров
  • Anhui Chest Hospital — Хэфэй
  • 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 — Шанхай
  • Zhoushan Hospital — Zhejiang

Идентификаторы

NCT: NCT07653945 · 2026-R2021-01

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗