Under way, not recruiting
Safety and Performance Evaluation of the RonovoTM Robotic Surgical Platform in Oncological Procedures
NCT07632638 · Instituto do Cancer do Estado de São Paulo · Updated 22 Sept 2026
- What is being tested
- RonovoTM Robotic Surgical Platform
- For
- Malignant Neoplasms; Cancer
- Kind of study
- Tests a treatment or device on volunteers. No drug phase (a device or procedure study).
- Who can join
- Ages 18 years and older. About 40 people. The full rules are on the registry page.
- Where
- Brazil
- When
- Starts or started 19 June 2026, ends Dec 2026. Registered 8 June 2026.
- Results
- None posted yet.
In the researchers' words
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.
Sites
- Instituto do Câncer do Estado de São Paulo - ICESPSão Paulo, São Paulo, Brazil