Safety and Performance Evaluation of the RonovoTM Robotic Surgical Platform in Oncological Procedures
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: RonovoTM Robotic Surgical Platform.
- Who it may be relevant to
- Registry conditions: Malignant Neoplasms, Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Brazil
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Safety and Technical Evaluation of a Robotic Platform (RonovoTM) in Elective Oncological Surgery: A Prospective, Single-Arm, Multi-Specialty Registry
Overview
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.
Detailed description
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
Interventions
- Device 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.
Primary outcome measures
- 30-day postoperative complication rate (Clavien-Dindo classification) [Time frame: 30 days after surgery]
- Intraoperative conversion rate [Time frame: Intraoperative (day of surgery)]
- Device-related technical failure rate [Time frame: Intraoperative (day of surgery)]
Secondary outcome measures (7)
- Total operative time [Time frame: Intraoperative (day of surgery)]
- Robot docking time [Time frame: Intraoperative (day of surgery)]
- Robotic console time [Time frame: Intraoperative (day of surgery)]
- Estimated blood loss [Time frame: Intraoperative (day of surgery)]
- Length of hospital stay [Time frame: Up to 90 days after surgery]
- 30-day and 90-day mortality rate [Time frame: 90 days after surgery]
- Adverse event profile [Time frame: 90 days after surgery]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Brazil · 1 center
- Instituto do Câncer do Estado de São Paulo - ICESP — São Paulo
Publications
- 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
Identifiers
NCT: NCT07632638 · 5462/2025 · 94890426.9.0000.0068