Safety and Performance Evaluation of the RonovoTM Robotic Surgical Platform in Oncological Procedures (CONSTELAR)
Safety and Technical Evaluation of a Robotic Platform (RonovoTM) in Elective Oncological Surgery: A Prospective, Single-Arm, Multi-Specialty Registry
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.
Обзор исследования
Статус
Условия
Вмешательство/лечение
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
Тип исследования
Регистрация (Оцененный)
Фаза
- Непригодный
Контакты и местонахождение
Места учебы
-
-
São Paulo
-
São Paulo, São Paulo, Бразилия, 05403-010
- Instituto do Câncer do Estado de São Paulo - ICESP
-
-
Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
Inclusion Criteria:
- Age ≥ 18 years
- Confirmed malignancy diagnosis
- Elective indication for robotic approach using RonovoTM
- Able to understand and sign informed consent
Exclusion Criteria:
- Formal contraindication to minimally invasive surgery
- Severe comorbidity prohibiting the procedure
- Refusal to participate or sign informed consent
- Emergency surgery
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Н/Д
- Интервенционная модель: Одногрупповое задание
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Экспериментальный: RonovoTM Robotic Surgery
All enrolled participants undergo elective oncological surgery using the 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. |
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
30-day postoperative complication rate (Clavien-Dindo classification)
Временное ограничение: 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). |
30 days after surgery
|
|
Intraoperative conversion rate
Временное ограничение: Intraoperative (day of surgery)
|
Proportion of procedures requiring conversion from robotic approach to conventional laparoscopy or open surgery (laparotomy). |
Intraoperative (day of surgery)
|
|
Device-related technical failure rate
Временное ограничение: 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. |
Intraoperative (day of surgery)
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Total operative time
Временное ограничение: Intraoperative (day of surgery)
|
Time in minutes from incision to closure |
Intraoperative (day of surgery)
|
|
Robot docking time
Временное ограничение: Intraoperative (day of surgery)
|
Time in minutes from trocar positioning to robot docking completion |
Intraoperative (day of surgery)
|
|
Robotic console time
Временное ограничение: Intraoperative (day of surgery)
|
Time in minutes from console start to undocking |
Intraoperative (day of surgery)
|
|
Estimated blood loss
Временное ограничение: Intraoperative (day of surgery)
|
Estimated intraoperative blood loss in milliliters. |
Intraoperative (day of surgery)
|
|
Length of hospital stay
Временное ограничение: Up to 90 days after surgery
|
Total number of days from surgery to hospital discharge. |
Up to 90 days after surgery
|
|
30-day and 90-day mortality rate
Временное ограничение: 90 days after surgery
|
Proportion of participants who died within 30 and 90 days of surgery, including cause of death classification. |
90 days after surgery
|
|
Adverse event profile
Временное ограничение: 90 days after surgery
|
Incidence, type, severity (CTCAE v5.0), seriousness, and causality of adverse events related to the procedure or device. |
90 days after surgery
|
Соавторы и исследователи
Следователи
- Главный следователь: Ulysses MD, PhD Ribeiro Jr, Instituto do Câncer do Estados de São Paulo (ICESP)
Публикации и полезные ссылки
Общие 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.
- 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.
- 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.
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Действительный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- 5462/2025
- 94890426.9.0000.0068 (Идентификатор реестра: Brazilian Ethics Approval (Plataforma Brasil))
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
Описание плана IPD
It has been decided not to share Individual Participant Data (IPD) related to the study for several reasons.Protecting the privacy of participants is a priority. Sharing IPD may expose sensitive information that, even when de-identified, can be traced back to individuals.
Furthermore, the complexity of the data makes sharing challenging without the risk of misunderstandings or misinterpretations, which could compromise the integrity of the research. Sharing IPD without the explicit consent of participants may violate ethical principles of respect and protection.
There is also a need to comply with regulatory guidelines governing data sharing to avoid potential legal issues. Finally, the focus will be on disseminating aggregated results that can benefit the scientific community and the public without compromising individual privacy.
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
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