Cancer, Malignant Neoplasms
Conditions
Keywords
Robotic surgery, Minimally invasive surgery, Oncological surgery
Brief summary
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
DEVICERonovoTM 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.
Sponsors
Instituto do Cancer do Estado de São Paulo
Ronovo (Shanghai) Medical Science and Technology Ltd
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
A Prospective, Single-Arm, Multi-Specialty Registry.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age ≥ 18 years 2. Confirmed malignancy diagnosis 3. Elective indication for robotic approach using RonovoTM 4. Able to understand and sign informed consent
Exclusion criteria
1. Formal contraindication to minimally invasive surgery 2. Severe comorbidity prohibiting the procedure 3. Refusal to participate or sign informed consent 4. Emergency surgery
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 30-day postoperative complication rate (Clavien-Dindo classification) | 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). |
| Intraoperative conversion rate | Intraoperative (day of surgery) | Proportion of procedures requiring conversion from robotic approach to conventional laparoscopy or open surgery (laparotomy). |
| Device-related technical failure rate | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Robotic console time | Intraoperative (day of surgery) | Time in minutes from console start to undocking |
| Estimated blood loss | Intraoperative (day of surgery) | Estimated intraoperative blood loss in milliliters. |
| Length of hospital stay | Up to 90 days after surgery | Total number of days from surgery to hospital discharge. |
| Adverse event profile | 90 days after surgery | Incidence, type, severity (CTCAE v5.0), seriousness, and causality of adverse events related to the procedure or device. |
| 30-day and 90-day mortality rate | 90 days after surgery | Proportion of participants who died within 30 and 90 days of surgery, including cause of death classification. |
| Total operative time | Intraoperative (day of surgery) | Time in minutes from incision to closure |
| Robot docking time | Intraoperative (day of surgery) | Time in minutes from trocar positioning to robot docking completion |
Countries
Brazil
Contacts
CONTACTUlysses Ribeiro Júnior, Principal Investigator, MD, Ph
PRINCIPAL_INVESTIGATORUlysses MD, PhD Ribeiro Jr
Instituto do Câncer do Estados de São Paulo (ICESP)
Outcome results
None listed