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.
Age ≥ 18 years
Confirmed malignancy diagnosis
Elective indication for robotic approach using RonovoTM
Able to understand and sign informed consent
Formal contraindication to minimally invasive surgery
Severe comorbidity prohibiting the procedure
Refusal to participate or sign informed consent
Emergency surgery
Single group
RonovoTM Robotic Surgical Platform
DeviceThe 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.
30-day postoperative complication rate (Clavien-Dindo classification)
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
Proportion of procedures requiring conversion from robotic approach to conventional laparoscopy or open surgery (laparotomy).
Device-related technical failure rate
Proportion of procedures in which a device technical failure occurred (hardware, software, camera/vision, connectivity, or power failure) and its clinical impact.
Total operative time
Time in minutes from incision to closure
Robot docking time
Time in minutes from trocar positioning to robot docking completion
Robotic console time
Time in minutes from console start to undocking
Estimated blood loss
Estimated intraoperative blood loss in milliliters.
Click on the lead sponsor to view all of their trials.
Instituto do Cancer do Estado de São Paulo
Lead sponsor
Ronovo (Shanghai) Medical Science and Technology Ltd
Collaborator
