Esta página foi traduzida automaticamente e a precisão da tradução não é garantida. Por favor, consulte o versão em inglês para um texto fonte.

AI Assistance for Detecting Active Bleeding During DSA Procedures

11 de setembro de 2026 atualizado por: Jian Lu, Zhongda Hospital

Real-Time DSA-VDet Assistance for Detecting Active Bleeding Across Multiple Anatomical Regions: A Multicenter, Prospective, Randomized, Open-Label, Blinded-Endpoint Controlled Trial

Clinically, DSA-VDet can continuously indicate suspected bleeding regions throughout a complete angiographic sequence and provide a second-reader opinion to the operator. It is expected to reduce the time required for frame-by-frame review and localization of culprit vessels, reduce missed detection of small, multiple, or unusually located bleeding sites, and improve consistency among physicians with different levels of experience. Faster culprit-vessel localization may also reduce repeat angiography, radiation exposure, and unnecessary superselective catheterization. These potential benefits will be tested in the prospective randomized trial; the study does not assume that the model will necessarily improve clinical outcomes. From a translational perspective, the study will establish a standardized temporal DSA database spanning multiple centers, devices, and anatomical regions, together with bleeding-site annotation standards, a model suitable for real-time deployment, and a pathway for clinical evaluation. These resources may provide a reproducible technical foundation for regional collaboration in emergency interventional care and AI-assisted interpretation in lower-resource hospitals.

The core value of this study is therefore to address the 'single-region, weak-temporal, algorithm-centered, clinically under-evaluated' limitations of existing models. Using multicenter DSA videos from multiple anatomical regions, the study will leverage contrast kinetics and motion information to improve detection of small bleeding sites and will progress from retrospective validation through controlled physician interpretation to a prospective randomized trial, providing a continuous evaluation from technical performance to clinical benefit.

Visão geral do estudo

Status

Ainda não está recrutando

Condições

Intervenção / Tratamento

Tipo de estudo

Intervencional

Inscrição (Estimado)

1324

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Locais de estudo

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China, 213003
        • Zhongda hospital
        • Contato:

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Não

Descrição

Inclusion Criteria:

  • age 18 years or older;
  • suspected acute active bleeding in an intracranial, solid-organ, pelvic, gastrointestinal, respiratory, great-vessel, or other relevant anatomical region requiring DSA-guided interventional diagnosis or treatment;
  • clinical suitability for the planned DSA procedure;
  • written informed consent from the patient or legally authorized representative before randomization whenever feasible, or eligibility for an ethics-approved deferred-consent pathway at an activated site when prior consent is impossible and treatment cannot be delayed.

Exclusion Criteria:

  • a history of severe allergic reaction to iodinated contrast medium or related medications that precludes the planned procedure;
  • severe coagulopathy or a platelet count below 50x10^9/L when interventional treatment is considered clinically inappropriate;
  • severe cardiac or pulmonary insufficiency that makes the planned procedure unsafe;
  • pregnancy or breastfeeding;
  • severe renal insufficiency or another condition that may substantially increase interventional risk;
  • inability to complete angiography safely according to the required workflow despite clinically appropriate support;
  • any other circumstance that, in the investigator's judgment, makes participation unsuitable. Impaired decision-making capacity alone will not be an exclusion if consent can be obtained from a legally authorized representative or through the ethics-approved deferred-consent pathway.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: DSA-VDet-assisted group
During DSA acquisition, DSA-VDet v1.0 will perform continuous frame-by-frame inference and continuously display suspected bleeding regions, confidence scores, and relevant frame indices. The operator will retain responsibility for the final diagnosis, selection of culprit vessels, and all angiographic and embolization decisions.
Dispositivo: DSA-VDet v1.0
During DSA acquisition, DSA-VDet v1.0 will perform continuous frame-by-frame inference and continuously display suspected bleeding regions, confidence scores, and relevant frame indices. The operator will retain responsibility for the final diagnosis, selection of culprit vessels, and all angiographic and embolization decisions.
Sem intervenção: Conventional-interpretation group
The operator will perform frame-by-frame interpretation using the conventional DSA equipment and established workflow, without access to DSA-VDet output. Images may undergo offline model analysis after completion of the index procedure for exploratory purposes, but those results must not be available for the index clinical decision.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
the time from the start of the first diagnostic DSA acquisition to achievement of the correct diagnostic endpoint
Prazo: Upon achievement of the correct diagnostic endpoint, an average of 1 hour
To determine whether real-time DSA-VDet v1.0 assistance shortens the time from the start of the first diagnostic DSA acquisition to achievement of the correct diagnostic endpoint, compared with conventional interpretation.
Upon achievement of the correct diagnostic endpoint, an average of 1 hour

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
the detection and localization performance of DSA-VDet
Prazo: Upon achievement of the correct diagnostic endpoint, an average of 1 hour
To evaluate the detection and localization performance of DSA-VDet in DSA sequences acquired across multiple anatomical regions; to assess its effects on interpretation accuracy, interpretation time, and interobserver agreement among interventional physicians with different levels of experience; and to compare total procedure duration, technical embolization success, repeat angiographic acquisitions, radiation exposure, contrast-medium volume, intraprocedural complications, and adverse events through postprocedure day 30 between the randomized groups.
Upon achievement of the correct diagnostic endpoint, an average of 1 hour
effects on interpretation accuracy
Prazo: Upon achievement of the correct diagnostic endpoint, an average of 1 hour
To evaluate the detection and localization performance of DSA-VDet in DSA sequences acquired across multiple anatomical regions; to assess its effects on interpretation accuracy, interpretation time, and interobserver agreement among interventional physicians with different levels of experience; and to compare total procedure duration, technical embolization success, repeat angiographic acquisitions, radiation exposure, contrast-medium volume, intraprocedural complications, and adverse events through postprocedure day 30 between the randomized groups.
Upon achievement of the correct diagnostic endpoint, an average of 1 hour
interpretation time
Prazo: Upon achievement of the correct diagnostic endpoint, an average of 1 hour
To evaluate the detection and localization performance of DSA-VDet in DSA sequences acquired across multiple anatomical regions; to assess its effects on interpretation accuracy, interpretation time, and interobserver agreement among interventional physicians with different levels of experience; and to compare total procedure duration, technical embolization success, repeat angiographic acquisitions, radiation exposure, contrast-medium volume, intraprocedural complications, and adverse events through postprocedure day 30 between the randomized groups.
Upon achievement of the correct diagnostic endpoint, an average of 1 hour
interobserver agreement among interventional physicians with different levels of experience
Prazo: Upon achievement of the correct diagnostic endpoint, an average of 1 hour
To evaluate the detection and localization performance of DSA-VDet in DSA sequences acquired across multiple anatomical regions; to assess its effects on interpretation accuracy, interpretation time, and interobserver agreement among interventional physicians with different levels of experience; and to compare total procedure duration, technical embolization success, repeat angiographic acquisitions, radiation exposure, contrast-medium volume, intraprocedural complications, and adverse events through postprocedure day 30 between the randomized groups.
Upon achievement of the correct diagnostic endpoint, an average of 1 hour

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Zhongda Hospital

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Estimado)

1 de outubro de 2026

Conclusão Primária (Estimado)

1 de outubro de 2027

Conclusão do estudo (Estimado)

30 de dezembro de 2027

Datas de inscrição no estudo

Enviado pela primeira vez

2 de setembro de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

11 de setembro de 2026

Primeira postagem (Real)

17 de setembro de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

17 de setembro de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

11 de setembro de 2026

Última verificação

1 de setembro de 2026

Mais Informações

Termos relacionados a este estudo

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • DSA-VDet

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

Se inscrever