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

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.

NCT Number	NCT07632638
Lead Sponsor	Instituto do Cancer do Estado de São Paulo Collaborators: Ronovo (Shanghai) Medical Science and Technology Ltd
Conditions	Malignant Neoplasms, Cancer
Enrollment	40 participants
Start Date	2026-06-19
Primary Completion	2026-09 (estimated)
Study Completion	2026-12 (estimated)
Updated on ClinicalTrials.gov	2026-07-02