Evaluation of RonovoTM Robotic Platform Safety and Performance in Adult Elective Cancer Surgeries

What this Trial Is About

Researchers are evaluating the safety and performance of the RonovoTM robotic surgical platform in adult patients undergoing elective cancer-related surgeries. This prospective, single-arm registry study includes patients from four surgical specialties Digestive Surgery, Thoracic Surgery, Urology, and Gynecology. The study aims to provide initial safety and feasibility data to support regulatory approval of the RonovoTM system in Latin America by tracking various surgical and clinical outcomes. Participants receive elective oncological surgery using the RonovoTM robotic platform, a device that allows surgeons to perform minimally invasive procedures through robotic arms controlled from a console. The study collects detailed intraoperative data such as docking time, console time, operative time, estimated blood loss, and any device-related technical failures. Outcomes are measured from preoperative screening through a 90-day follow-up period, including complication rates, conversion to other surgical methods, hospital stay length, ICU admissions, and oncological results. Throughout the study, participants undergo assessments including demographic and medical history collection, oncological staging, and monitoring for adverse events and complications classified by standard criteria. Data on surgical outcomes and device performance are gathered during and after surgery, with follow-up visits extending up to 90 days postoperatively. The primary focus is on safety measures such as postoperative complication rates, technical device failures, and conversion rates during surgery, ensuring comprehensive evaluation of the RonovoTM systems use in cancer surgeries.

Safety and Performance Evaluation of the RonovoTM Robotic Surgical Platform in Oncological Procedures