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Active, not recruiting

NCT Number: NCT07632638

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

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.

Active, not recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Malignant Neoplasms Cancer Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Instituto do Câncer do Estado de São Paulo - ICESP

São Paulo, 05403-010, Brazil

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

RonovoTM Robotic Surgical Platform

Device

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 outcomes

  1. 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).

  2. Intraoperative conversion rate

    Time frame: Intraoperative (day of surgery)

    Proportion of procedures requiring conversion from robotic approach to conventional laparoscopy or open surgery (laparotomy).

  3. 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.

Secondary outcomes

  1. Total operative time

    Time frame: Intraoperative (day of surgery)

    Time in minutes from incision to closure

  2. Robot docking time

    Time frame: Intraoperative (day of surgery)

    Time in minutes from trocar positioning to robot docking completion

  3. Robotic console time

    Time frame: Intraoperative (day of surgery)

    Time in minutes from console start to undocking

  4. Estimated blood loss

    Time frame: Intraoperative (day of surgery)

    Estimated intraoperative blood loss in milliliters.

  5. Length of hospital stay

    Time frame: Up to 90 days after surgery

    Total number of days from surgery to hospital discharge.

  6. 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.

  7. 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.

Sponsors and collaborators

Lead sponsor

Instituto do Cancer do Estado de São Paulo

Other

Collaborators

  • Ronovo (Shanghai) Medical Science and Technology Ltd

Registry information

Official study title

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

Acronym: CONSTELAR

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jun 8, 2026
Registry last updated
Sep 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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