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

Официальное название

Safety and Technical Evaluation of a Robotic Platform (RonovoTM) in Elective Oncological Surgery: A Prospective, Single-Arm, Multi-Specialty Registry

Обзор

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.

Подробное описание

The RonovoTM is a novel robotic surgical platform developed for minimally invasive surgery. CONSTELAR is designed as a first-in-clinical-use registry to systematically collect safety, technical performance, and short-term clinical outcome data. Eligible participants are adults (≥18 years) with confirmed malignancy diagnoses scheduled for elective robotic surgery using the RonovoTM system. Exclusion criteria include formal contraindications to minimally invasive surgery, severe prohibitive comorbidities, refusal to consent, or emergency surgery. Data collection spans from preoperative screening through 90-day follow-up, capturing demographics, comorbidities, oncological staging (Tumor, Node, Metastasis - TNM staging system 8th edition ), operative details (docking, console, and anesthesia times), intraoperative events, postoperative complications, adverse events, device technical failures, and oncological surgical outcomes. Adverse events are classified using Common Terminology Criteria for Adverse Events (CTCAE) v5.0 and causality assessment relative to the RonovoTM device. The study follows Brazilian Health Regulatory Agency (ANVISA) Collegiate Board Resolution (RDC) 837/2023 regulatory requirements

Вмешательства

• Устройство 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.

Первичные конечные точки

• 30-day postoperative complication rate (Clavien-Dindo classification) [Срок оценки: 30 days after surgery]
• Intraoperative conversion rate [Срок оценки: Intraoperative (day of surgery)]
• Device-related technical failure rate [Срок оценки: Intraoperative (day of surgery)]

Вторичные конечные точки (7)

• Total operative time [Срок оценки: Intraoperative (day of surgery)]
• Robot docking time [Срок оценки: Intraoperative (day of surgery)]
• Robotic console time [Срок оценки: Intraoperative (day of surgery)]
• Estimated blood loss [Срок оценки: Intraoperative (day of surgery)]
• Length of hospital stay [Срок оценки: Up to 90 days after surgery]
• 30-day and 90-day mortality rate [Срок оценки: 90 days after surgery]
• Adverse event profile [Срок оценки: 90 days after surgery]

Критерии участия

Критерии включения

• Age ≥ 18 years
• Confirmed malignancy diagnosis
• Elective indication for robotic approach using RonovoTM
• Able to understand and sign informed consent

Критерии исключения

• Formal contraindication to minimally invasive surgery
• Severe comorbidity prohibiting the procedure
• Refusal to participate or sign informed consent
• Emergency surgery

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Бразилия · 1 центр

• Instituto do Câncer do Estado de São Paulo - ICESP — São Paulo

Публикации

• Nandy K, Patkar S, Varty G, Shah T, Goel M. Outcomes of Robotic Surgery in a Single-institution, High-volume Hepatobiliary Oncology Unit. Indian J Surg Oncol. 2024 May;15(Suppl 2):289-296. doi: 10.1007/s13193-024-01873-6. Epub 2024 Jan 16. PMID 38818004
• Liu Y, Zhao Z, Xu P, Li Y, Chang W, Ji M. Initial experience with the Carina platform in robotic-assisted hysterectomy for gynecological malignant disease. Surg Endosc. 2025 Apr;39(4):2346-2353. doi: 10.1007/s00464-025-11588-6. Epub 2025 Feb 18. PMID 39966128
• Pokhrel G, Wang Z, Cui J, Jin B, Zheng H, Tao J, Fan Y, Liu Y, Zhan Y, Yu S, Dong B, Zhang X. Initial experience with the novel modular robotic system Carina in urology: a prospective study on safety feasibility and surgical settings. Sci Rep. 2025 Apr 12;15(1):12686. doi: 10.1038/s41598-025-97411-7. PMID 40221629

Идентификаторы

NCT: NCT07632638 · 5462/2025 · 94890426.9.0000.0068

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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