Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

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

2. juni 2026 opdateret af: 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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

40

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Brasilien
    • São Paulo
      • São Paulo, São Paulo, Brasilien, 05403-010
        • Instituto do Cancer do Estado de Sao Paulo - ICESP
        • Kontakt:
        • Ledende efterforsker:
          • Ulysses Ribeiro Júnior, MD, PhD
        • Underforsker:
          • Alexandre S e Silva, MD

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: RonovoTM Robotic Surgery
All enrolled participants undergo elective oncological surgery using the RonovoTM robotic surgical platform.
Enhed: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
30-day postoperative complication rate (Clavien-Dindo classification)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)

Sekundære resultatmål

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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Instituto do Cancer do Estado de São Paulo

Samarbejdspartnere

Ronovo (Shanghai) Medical Science and Technology Ltd

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. juni 2026

Primær færdiggørelse (Anslået)

1. september 2026

Studieafslutning (Anslået)

1. december 2026

Datoer for studieregistrering

Først indsendt

2. juni 2026

Først indsendt, der opfyldte QC-kriterier

2. juni 2026

Først opslået (Faktiske)

8. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

8. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

2. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

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

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

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.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med RonovoTM Robotic Surgical Platform

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Israel

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner