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

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

Study 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.

Eligibility

Primary outcome measure(s)

• 30-day postoperative complication rate (Clavien-Dindo classification) — 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 — Intraoperative (day of surgery)
  Proportion of procedures requiring conversion from robotic approach to conventional laparoscopy or open surgery (laparotomy).
• Device-related technical failure rate — 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.

Trial sites (1)

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