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

June 2, 2026 updated by: Instituto do Cancer do Estado de São Paulo

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, 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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 (TNM 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 CTCAE v5.0 and causality assessment relative to the RonovoTM device. The study follows ANVISA RDC 837/2023 regulatory requirements

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Brazil
    • São Paulo
      • São Paulo, São Paulo, Brazil, 05403-010
        • Instituto do Câncer do Estado de São Paulo - ICESP
        • Contact:
        • Principal Investigator:
          • Ulysses Ribeiro Júnior, MD, PhD
        • Sub-Investigator:
          • Alexandre S e Silva, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: RonovoTM Robotic Surgery
All enrolled participants undergo elective oncological surgery using the RonovoTM robotic surgical platform.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
30-day postoperative complication rate (Clavien-Dindo classification)
Time Frame: 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
Time Frame: 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
Time Frame: 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)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total operative time
Time Frame: Intraoperative (day of surgery)
Time in minutes from incision to closure
Intraoperative (day of surgery)
Robot docking time
Time Frame: Intraoperative (day of surgery)
Time in minutes from trocar positioning to robot docking completion
Intraoperative (day of surgery)
Robotic console time
Time Frame: Intraoperative (day of surgery)
Time in minutes from console start to undocking
Intraoperative (day of surgery)
Estimated blood loss
Time Frame: Intraoperative (day of surgery)
Estimated intraoperative blood loss in milliliters.
Intraoperative (day of surgery)
Length of hospital stay
Time Frame: 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
Time Frame: 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
Time Frame: 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto do Cancer do Estado de São Paulo

Collaborators

Ronovo (Shanghai) Medical Science and Technology Ltd

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

June 2, 2026

First Submitted That Met QC Criteria

June 2, 2026

First Posted (Actual)

June 8, 2026

Study Record Updates

Last Update Posted (Actual)

June 8, 2026

Last Update Submitted That Met QC Criteria

June 2, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5462/2025
  • CAAE: 94890426.9.0000.0068 (Registry Identifier: Brazilian Ethics Approval (Plataforma Brasil))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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, evenwhen de-identified, can be traced back to individuals.

Furthermore, the complexity of the data makes sharing challenging without the risk of misunderstandingsor misinterpretations, which could compromise the integrity of the research. Sharing IPD without theexplicit 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 legalissues. Finally, the focus will be on disseminating aggregated results that can benefit the scientificcommunity and the public without compromising individual privacy.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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