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Malignant NeoplasmsCONSTELARNCT07632638

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

A study testing RonovoTM Robotic Surgical Platform in people with Malignant Neoplasms and Cancer, run by Instituto do Cancer do Estado de São Paulo at 1 site in Brazil.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Malignant Neoplasms, Cancer
What is being tested?
RonovoTM Robotic Surgical Platform
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteBrazil
Study dates
19 Jun 2026to Dec 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥ 18 years
  • Confirmed malignancy diagnosis
  • Elective indication for robotic approach using RonovoTM
  • Able to understand and sign informed consent

Who cannot join

  • Formal contraindication to minimally invasive surgery
  • Severe comorbidity prohibiting the procedure
  • Refusal to participate or sign informed consent
  • Emergency surgery

Trial locations and contacts

1 site in 1 country.

Brazil1 site

  • Instituto do Câncer do Estado de São Paulo - ICESP

    São Paulo, São Paulo, 05403-010

Other trials in Brazil

About this study

Official title: 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.

Read the 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

Being tested
RonovoTM Robotic Surgical Platform
Keywords
Robotic surgery, Minimally invasive surgery, Oncological surgery
Medical subject headings
Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RonovoTM Robotic Surgical PlatformDevice

    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.

Study groups in NCT07632638
Study groupRoleWhat they receive
RonovoTM Robotic SurgeryExperimentalAll enrolled participants undergo elective oncological surgery using the RonovoTM robotic surgical platform.
Receives: Device: RonovoTM Robotic Surgical Platform

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 30-day postoperative complication rate (Clavien-Dindo classification)

    Proportion of participants experiencing any postoperative complication within 30 days of surgery, graded according to the Clavien-Dindo classification system (Grades I-V).

    Measured: 30 days after surgery

  2. Intraoperative conversion rate

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

    Measured: Intraoperative (day of surgery)

  3. Device-related technical failure rate

    Proportion of procedures in which a device technical failure occurred (hardware, software, camera/vision, connectivity, or power failure) and its clinical impact.

    Measured: Intraoperative (day of surgery)

Secondary outcomes (7)

  1. Total operative time

    Time in minutes from incision to closure

    Measured: Intraoperative (day of surgery)

  2. Robot docking time

    Time in minutes from trocar positioning to robot docking completion

    Measured: Intraoperative (day of surgery)

  3. Robotic console time

    Time in minutes from console start to undocking

    Measured: Intraoperative (day of surgery)

  4. Estimated blood loss

    Estimated intraoperative blood loss in milliliters.

    Measured: Intraoperative (day of surgery)

  5. Length of hospital stay

    Total number of days from surgery to hospital discharge.

    Measured: Up to 90 days after surgery

  6. 30-day and 90-day mortality rate

    Proportion of participants who died within 30 and 90 days of surgery, including cause of death classification.

    Measured: 90 days after surgery

  7. Adverse event profile

    Incidence, type, severity (CTCAE v5.0), seriousness, and causality of adverse events related to the procedure or device.

    Measured: 90 days after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Jun 2026
  2. Study start19 Jun 2026
  3. Primary completion29 Aug 2026
  4. Study completionDec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
A Prospective, Single-Arm, Multi-Specialty Registry.
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07632638
Sponsor's protocol ID
5462/2025
Other IDs
94890426.9.0000.0068
Acronym
CONSTELAR
Status last verified
Sep 2026
First submitted
2 Jun 2026
Last updated
22 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: 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.

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.

    PubMed 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.

    PubMed 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.

    PubMed 40221629

Questions about this trial

What is this clinical trial studying?

A study testing RonovoTM Robotic Surgical Platform in people with Malignant Neoplasms and Cancer, run by Instituto do Cancer do Estado de São Paulo at 1 site in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 22 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

30-day postoperative complication rate (Clavien-Dindo classification) (time frame: 30 days after surgery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07632638, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2026.

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