Safety and Performance Evaluation of the RonovoTM Robotic Surgical Platform in Oncological Procedures (CONSTELAR)
2026年7月1日 更新者：Instituto do Cancer do Estado de São Paulo
Safety and Technical Evaluation of a Robotic Platform (RonovoTM) in Elective Oncological Surgery: A Prospective, Single-Arm, Multi-Specialty Registry
CONSTELAR is a prospective, single-arm, multi-specialty registry designed to evaluate the safety and intraoperative performance of the RonovoTM robotic surgical platform in adult patients undergoing elective oncological surgery.
The study enrolls patients across four surgical specialties (Digestive Surgery, Thoracic Surgery, Urology, and Gynecology) at a single academic center.
Primary endpoints include 30-day and 90-day complication rates (Clavien-Dindo classification), operative times, conversion rates, estimated blood loss, and device-related technical failures.
Secondary endpoints encompass length of hospital stay, Intensive Care Unit (ICU) admission, readmission/reoperation rates, and oncological surgical outcomes (resection margins, lymph node harvest).
The study aims to provide initial safety and feasibility data to support the regulatory pathway for the RonovoTM platform in Latin America.
研究概览
详细说明
The RonovoTM is a novel robotic surgical platform developed for minimally invasive surgery.
CONSTELAR is designed as a first-in-clinical-use registry to systematically collect safety, technical performance, and short-term clinical outcome data.
Eligible participants are adults (≥18 years) with confirmed malignancy diagnoses scheduled for elective robotic surgery using the RonovoTM system.
Exclusion criteria include formal contraindications to minimally invasive surgery, severe prohibitive comorbidities, refusal to consent, or emergency surgery.
Data collection spans from preoperative screening through 90-day follow-up, capturing demographics, comorbidities, oncological staging (Tumor, Node, Metastasis - TNM staging system 8th edition ), operative details (docking, console, and anesthesia times), intraoperative events, postoperative complications, adverse events, device technical failures, and oncological surgical outcomes.
Adverse events are classified using Common Terminology Criteria for Adverse Events (CTCAE) v5.0 and causality assessment relative to the RonovoTM device.
The study follows Brazilian Health Regulatory Agency (ANVISA) Collegiate Board Resolution (RDC) 837/2023 regulatory requirements
研究类型
介入性
注册 (估计的)
40
阶段
- 不适用
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。
学习联系方式
- 姓名：Ulysses Ribeiro Júnior, Principal Investigator, MD, Ph
- 电话号码：+55 11 3893-3515
- 邮箱：icesp.pesquisa.np@hc.fm.usp.br
学习地点
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São Paulo
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São Paulo、São Paulo、巴西、05403-010
- 招聘中
- Instituto do Câncer do Estado de São Paulo - ICESP
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接触：
- Núcleo de Pesquisa Institucional
- 电话号码：+55 11 3893-3515
- 邮箱：icesp.pesquisa.np@hc.fm.usp.br
-
副研究员：
- Alexandre S e Silva, MD
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首席研究员：
- Ulysses Ribeiro Jr, MD, PhD
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副研究员：
- Carlos FS Marques, MD
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副研究员：
- Lucas F Sobrado, MD
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副研究员：
- Ricardo Z Abdalla, MD
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副研究员：
- Rodrigo J Oliveira, MD
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副研究员：
- Ricardo M Terra, MD
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副研究员：
- Pedro HX Nabuco de Araújo, MD
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副研究员：
- Jesus P Carvalho, MD
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副研究员：
- Rodrigo P Fernandes, MD
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副研究员：
- Rodolpho T Kleine, MD
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副研究员：
- Arnaldo JC Fazoli, MD
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副研究员：
- Mauricio D Cordeiro, MD
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副研究员：
- Rafael F Coelho, MD
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副研究员：
- André R Dias, MD
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副研究员：
- Gabriel CA Silva, MD
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副研究员：
- William C Nahas, MD, PhD
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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
- 成人
- 年长者
接受健康志愿者
不
描述
Inclusion Criteria:
- Age ≥ 18 years
- Confirmed malignancy diagnosis
- Elective indication for robotic approach using RonovoTM
- Able to understand and sign informed consent
Exclusion Criteria:
- Formal contraindication to minimally invasive surgery
- Severe comorbidity prohibiting the procedure
- Refusal to participate or sign informed consent
- Emergency surgery
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
- 主要用途：治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：RonovoTM Robotic Surgery
All enrolled participants undergo elective oncological surgery using the RonovoTM robotic surgical platform.
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The RonovoTM is a robotic surgical platform used to perform minimally invasive oncological surgical procedures.
The surgeon operates from a console controlling robotic arms with endoscopic instruments.
The platform is used for the complete surgical procedure from docking through console operation to undocking.
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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 |
|---|---|---|
|
30-day postoperative complication rate (Clavien-Dindo classification)
大体时间：30 days after surgery
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Proportion of participants experiencing any postoperative complication within 30 days of surgery, graded according to the Clavien-Dindo classification system (Grades I-V).
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30 days after surgery
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Intraoperative conversion rate
大体时间：Intraoperative (day of surgery)
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Proportion of procedures requiring conversion from robotic approach to conventional laparoscopy or open surgery (laparotomy).
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Intraoperative (day of surgery)
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Device-related technical failure rate
大体时间：Intraoperative (day of surgery)
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Proportion of procedures in which a device technical failure occurred (hardware, software, camera/vision, connectivity, or power failure) and its clinical impact.
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Intraoperative (day of surgery)
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Total operative time
大体时间：Intraoperative (day of surgery)
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Time in minutes from incision to closure
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Intraoperative (day of surgery)
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Robot docking time
大体时间：Intraoperative (day of surgery)
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Time in minutes from trocar positioning to robot docking completion
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Intraoperative (day of surgery)
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Robotic console time
大体时间：Intraoperative (day of surgery)
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Time in minutes from console start to undocking
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Intraoperative (day of surgery)
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Estimated blood loss
大体时间：Intraoperative (day of surgery)
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Estimated intraoperative blood loss in milliliters.
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Intraoperative (day of surgery)
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Length of hospital stay
大体时间：Up to 90 days after surgery
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Total number of days from surgery to hospital discharge.
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Up to 90 days after surgery
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30-day and 90-day mortality rate
大体时间：90 days after surgery
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Proportion of participants who died within 30 and 90 days of surgery, including cause of death classification.
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90 days after surgery
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Adverse event profile
大体时间：90 days after surgery
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Incidence, type, severity (CTCAE v5.0), seriousness, and causality of adverse events related to the procedure or device.
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90 days after surgery
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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。
调查人员
- 首席研究员：Ulysses MD, PhD Ribeiro Jr、Instituto do Câncer do Estados de São Paulo (ICESP)
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Nandy K, Patkar S, Varty G, Shah T, Goel M. Outcomes of Robotic Surgery in a Single-institution, High-volume Hepatobiliary Oncology Unit. Indian J Surg Oncol. 2024 May;15(Suppl 2):289-296. doi: 10.1007/s13193-024-01873-6. Epub 2024 Jan 16.
- Liu Y, Zhao Z, Xu P, Li Y, Chang W, Ji M. Initial experience with the Carina platform in robotic-assisted hysterectomy for gynecological malignant disease. Surg Endosc. 2025 Apr;39(4):2346-2353. doi: 10.1007/s00464-025-11588-6. Epub 2025 Feb 18.
- Pokhrel G, Wang Z, Cui J, Jin B, Zheng H, Tao J, Fan Y, Liu Y, Zhan Y, Yu S, Dong B, Zhang X. Initial experience with the novel modular robotic system Carina in urology: a prospective study on safety feasibility and surgical settings. Sci Rep. 2025 Apr 12;15(1):12686. doi: 10.1038/s41598-025-97411-7.
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6月19日
初级完成 (估计的)
2026年9月1日
研究完成 (估计的)
2026年12月1日
研究注册日期
首次提交
2026年6月2日
首先提交符合 QC 标准的
2026年6月2日
首次发布 (实际的)
2026年6月8日
研究记录更新
最后更新发布 (实际的)
2026年7月2日
上次提交的符合 QC 标准的更新
2026年7月1日
最后验证
2026年7月1日
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- 5462/2025
- 94890426.9.0000.0068 (注册表标识符：Brazilian Ethics Approval (Plataforma Brasil))
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
不
IPD 计划说明
It has been decided not to share Individual Participant Data (IPD) related to the study for several reasons.Protecting the privacy of participants is a priority. Sharing IPD may expose sensitive information that, even when de-identified, can be traced back to individuals.
Furthermore, the complexity of the data makes sharing challenging without the risk of misunderstandings or misinterpretations, which could compromise the integrity of the research. Sharing IPD without the explicit consent of participants may violate ethical principles of respect and protection.
There is also a need to comply with regulatory guidelines governing data sharing to avoid potential legal issues. Finally, the focus will be on disseminating aggregated results that can benefit the scientific community and the public without compromising individual privacy.
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.