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Safety and Performance Evaluation of the RonovoTM Robotic Surgical Platform in Oncological Procedures
Sponsor: Instituto do Cancer do Estado de São Paulo
Summary
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.
Official title: Safety and Technical Evaluation of a Robotic Platform (RonovoTM) in Elective Oncological Surgery: A Prospective, Single-Arm, Multi-Specialty Registry
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
40
Start Date
2026-06
Completion Date
2026-12
Last Updated
2026-06-25
Healthy Volunteers
No
Conditions
Interventions
RonovoTM Robotic Surgical Platform
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.
Locations (1)
Instituto do Câncer do Estado de São Paulo - ICESP
São Paulo, São Paulo, Brazil