Hugo™ Robotic Assisted Surgery (RAS) System in Prostatectomy Patients Treated in an ASC Setting
A Single-center Study of Robotic Prostatectomy Surgeries Performed Using the Medtronic Hugo™ Robotic Assisted Surgery (RAS) System in an Ambulatory Surgical Center Setting
A Single-center Study of Robotic Prostatectomy Surgeries Performed using the Medtronic Hugo™ Robotic Assisted Surgery (RAS) System in an Ambulatory Surgical Center Setting
Visão geral do estudo
Status
Condições
Descrição detalhada
The purpose of this study is to collect and analyze clinical, procedural/operational and economics data on the commercial use of the Hugo™ Robotic Assisted Surgery (RAS) System in prostatectomy patients treated in an ASC setting at the Central Ohio Urology Group (COUG).
This data will address a current evidence gap by providing insights into clinical outcomes, learning curve, procedural efficiency, patient recovery, and economic metrics at COUG. The study also aims to demonstrate the feasibility and benefits of performing RAS in an ASC setting, thereby advancing the adoption of Hugo™ RAS in this growing care setting.
Tipo de estudo
Inscrição (Estimado)
Contactos e Locais
Locais de estudo
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Ohio
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Columbus, Ohio, Estados Unidos, 43230
- Recrutamento
- Central Ohio Urology Group
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Contato:
- Shayna Phillips Research Manager
- Número de telefone: 614-396-2684
- E-mail: shayna.phillips@centralohiourology.com
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Método de amostragem
População do estudo
All male patients aged 18 years or older diagnosed with prostate cancer who are treated with robotic surgery using the Hugo™ RAS System.
Descrição
Inclusion Criteria:
- Subjects (male) ≥ 18 years old
- Subject has been indicated for a radical prostatectomy surgical procedure
- Subject is able to be treated with robotic surgery
- Subject is willing to participate and consents to participate, as documented by signed Institutional Review Board (IRB) approved informed consent form
Exclusion Criteria:
- Contraindicated for treatment with the Hugo™ RAS System in accordance with the commercial Instructions for Use and local regulations
- Subject is participating in another clinical investigation at the time of enrollment or has planned participation in another clinical investigation at any time during this study that may influence the results of this study
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Modelos de observação: CASE_ONLY
- Perspectivas de Tempo: PROSPECTIVE
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Incidence of Perioperative Complications
Prazo: From first incision through skin closure
|
Number of participants experiencing an intraoperative complication following robot-assisted radical prostatectomy performed using the Hugo™ RAS System. Complications will be classified according to institutional standards and summarized by severity. |
From first incision through skin closure
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Incidence of Postoperative Complications
Prazo: From the end of the procedure through 90 days post-procedure
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Number of participants experiencing a postoperative complication following robot-assisted radical prostatectomy performed using the Hugo™ RAS System. Complications will be classified according to institutional standards and summarized by severity. |
From the end of the procedure through 90 days post-procedure
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Conversion to Alternative Surgical Approach
Prazo: From first incision through skin closure
|
Number of procedures converted from robotic-assisted surgery using the Hugo™ RAS System to an open, laparoscopic, or other surgical approach. |
From first incision through skin closure
|
Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Operative Time
Prazo: Up to 340 minutes
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Operative time shall be collected through the length of the procedure. Assessed on the day of surgery |
Up to 340 minutes
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Operating Room Turnover
Prazo: From completion of the procedure (skin closure) until operating room readiness for the subsequent case, assessed on the day of surgery
|
Time from completion of a procedure until the operating room is ready for the subsequent case |
From completion of the procedure (skin closure) until operating room readiness for the subsequent case, assessed on the day of surgery
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Total Procedure Cost
Prazo: From the date of surgery through completion of associated ambulatory surgical center billing
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Total direct Ambulatory Surgery Center cost associated with robot-assisted radical prostatectomy performed using the Hugo™ RAS System |
From the date of surgery through completion of associated ambulatory surgical center billing
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Surgeon Learning Curve
Prazo: From the surgeon's first patient procedure through the last patient procedure
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Change in operative time across sequential prostatectomy cases performed using the Hugo™ RAS System as a measure of surgeon proficiency acquisition |
From the surgeon's first patient procedure through the last patient procedure
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Ronney Abaza, MD, Central Ohio Urology Group
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- RAS
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Informações sobre medicamentos e dispositivos, documentos de estudo
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