Safety and Technical Evaluation of a Robotic Platform (RonovoTM) in Elective Oncological Surgery: A Prospective, Single-Arm, Multi-Specialty Registry
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- 30-day postoperative complication rate (Clavien-Dindo classification)
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •Confirmed malignancy diagnosis
- •Elective indication for robotic approach using RonovoTM
- •Able to understand and sign informed consent
排除标准
- •Formal contraindication to minimally invasive surgery
- •Severe comorbidity prohibiting the procedure
- •Refusal to participate or sign informed consent
- •Emergency surgery
研究组 & 干预措施
RonovoTM Robotic Surgery
All enrolled participants undergo elective oncological surgery using the RonovoTM robotic surgical platform.
干预措施: RonovoTM Robotic Surgical Platform (Device)
结局指标
主要结局
30-day postoperative complication rate (Clavien-Dindo classification)
时间窗: 30 days after surgery
Proportion of participants experiencing any postoperative complication within 30 days of surgery, graded according to the Clavien-Dindo classification system (Grades I-V).
Intraoperative conversion rate
时间窗: Intraoperative (day of surgery)
Proportion of procedures requiring conversion from robotic approach to conventional laparoscopy or open surgery (laparotomy).
Device-related technical failure rate
时间窗: Intraoperative (day of surgery)
Proportion of procedures in which a device technical failure occurred (hardware, software, camera/vision, connectivity, or power failure) and its clinical impact.
次要结局
- Robotic console time(Intraoperative (day of surgery))
- Estimated blood loss(Intraoperative (day of surgery))
- Length of hospital stay(Up to 90 days after surgery)
- Total operative time(Intraoperative (day of surgery))
- Robot docking time(Intraoperative (day of surgery))
- 30-day and 90-day mortality rate(90 days after surgery)
- Adverse event profile(90 days after surgery)