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Hugo™ Robotic Assisted Surgery (RAS) System in Prostatectomy Patients Treated in an ASC Setting

2026年11月12日更新者：Central Ohio Urology Group

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

研究概览

地位

招聘中

条件

前列腺癌（诊断）

详细说明

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.

研究类型

观察性的

注册 (估计的)

100

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

美国
- Ohio
  - Columbus、Ohio、美国、43230
    - 招聘中
    - Central Ohio Urology Group
    - 接触：
      
      Shayna Phillips Research Manager
      
      电话号码：614-396-2684
      
      邮箱：shayna.phillips@centralohiourology.com

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

男性

取样方法

非概率样本

研究人群

All male patients aged 18 years or older diagnosed with prostate cancer who are treated with robotic surgery using the Hugo™ RAS System.

描述

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

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

观测模型：CASE_ONLY
时间观点：PROSPECTIVE

研究衡量的是什么？

主要结果指标

结果测量	措施说明	大体时间
Incidence of Perioperative Complications 大体时间：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
Incidence of Postoperative Complications 大体时间：From the end of the procedure through 90 days post-procedure	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
Conversion to Alternative Surgical Approach 大体时间：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

其他结果措施

结果测量	措施说明	大体时间
Operative Time 大体时间：Up to 340 minutes	Operative time shall be collected through the length of the procedure. Assessed on the day of surgery	Up to 340 minutes
Operating Room Turnover 大体时间：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
Total Procedure Cost 大体时间：From the date of surgery through completion of associated ambulatory surgical center billing	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
Surgeon Learning Curve 大体时间：From the surgeon's first patient procedure through the last patient procedure	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

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Central Ohio Urology Group

合作者

Medtronic

调查人员

首席研究员：Ronney Abaza, MD、Central Ohio Urology Group

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年10月27日

初级完成 (估计的)

2028年9月30日

研究完成 (估计的)

2028年9月30日

研究注册日期

首次提交

2026年6月9日

首先提交符合 QC 标准的

2026年10月9日

首次发布 (实际的)

2026年10月15日

研究记录更新

最后更新发布 (实际的)

2026年11月13日

上次提交的符合 QC 标准的更新

2026年11月12日

最后验证

2026年11月1日