Safety and Performance Evaluation of the RonovoTM Robotic Surgical Platform in Oncological Procedures (CONSTELAR)
1. juli 2026 oppdatert av: 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, 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.
Studieoversikt
Status
Rekruttering
Forhold
Intervensjon / Behandling
Detaljert 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 (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
Studietype
Intervensjonell
Registrering (Antatt)
40
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Ulysses Ribeiro Júnior, Principal Investigator, MD, Ph
- Telefonnummer: +55 11 3893-3515
- E-post: icesp.pesquisa.np@hc.fm.usp.br
Studiesteder
-
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São Paulo
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São Paulo, São Paulo, Brasil, 05403-010
- Rekruttering
- Instituto do Câncer do Estado de São Paulo - ICESP
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Ta kontakt med:
- Núcleo de Pesquisa Institucional
- Telefonnummer: +55 11 3893-3515
- E-post: icesp.pesquisa.np@hc.fm.usp.br
-
Underetterforsker:
- Alexandre S e Silva, MD
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Hovedetterforsker:
- Ulysses Ribeiro Jr, MD, PhD
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Underetterforsker:
- Carlos FS Marques, MD
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Underetterforsker:
- Lucas F Sobrado, MD
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Underetterforsker:
- Ricardo Z Abdalla, MD
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Underetterforsker:
- Rodrigo J Oliveira, MD
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Underetterforsker:
- Ricardo M Terra, MD
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Underetterforsker:
- Pedro HX Nabuco de Araújo, MD
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Underetterforsker:
- Jesus P Carvalho, MD
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Underetterforsker:
- Rodrigo P Fernandes, MD
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Underetterforsker:
- Rodolpho T Kleine, MD
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Underetterforsker:
- Arnaldo JC Fazoli, MD
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Underetterforsker:
- Mauricio D Cordeiro, MD
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Underetterforsker:
- Rafael F Coelho, MD
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Underetterforsker:
- André R Dias, MD
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Underetterforsker:
- Gabriel CA Silva, MD
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Underetterforsker:
- William C Nahas, MD, PhD
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Beskrivelse
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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: RonovoTM Robotic Surgery
All enrolled participants undergo elective oncological surgery using the RonovoTM robotic surgical platform.
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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.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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30-day postoperative complication rate (Clavien-Dindo classification)
Tidsramme: 30 days after surgery
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Proportion of participants experiencing any postoperative complication within 30 days of surgery, graded according to the Clavien-Dindo classification system (Grades I-V).
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30 days after surgery
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Intraoperative conversion rate
Tidsramme: Intraoperative (day of surgery)
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Proportion of procedures requiring conversion from robotic approach to conventional laparoscopy or open surgery (laparotomy).
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Intraoperative (day of surgery)
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Device-related technical failure rate
Tidsramme: Intraoperative (day of surgery)
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Proportion of procedures in which a device technical failure occurred (hardware, software, camera/vision, connectivity, or power failure) and its clinical impact.
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Intraoperative (day of surgery)
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Total operative time
Tidsramme: Intraoperative (day of surgery)
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Time in minutes from incision to closure
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Intraoperative (day of surgery)
|
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Robot docking time
Tidsramme: Intraoperative (day of surgery)
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Time in minutes from trocar positioning to robot docking completion
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Intraoperative (day of surgery)
|
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Robotic console time
Tidsramme: Intraoperative (day of surgery)
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Time in minutes from console start to undocking
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Intraoperative (day of surgery)
|
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Estimated blood loss
Tidsramme: Intraoperative (day of surgery)
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Estimated intraoperative blood loss in milliliters.
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Intraoperative (day of surgery)
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Length of hospital stay
Tidsramme: Up to 90 days after surgery
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Total number of days from surgery to hospital discharge.
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Up to 90 days after surgery
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30-day and 90-day mortality rate
Tidsramme: 90 days after surgery
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Proportion of participants who died within 30 and 90 days of surgery, including cause of death classification.
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90 days after surgery
|
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Adverse event profile
Tidsramme: 90 days after surgery
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Incidence, type, severity (CTCAE v5.0), seriousness, and causality of adverse events related to the procedure or device.
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90 days after surgery
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Ulysses MD, PhD Ribeiro Jr, Instituto do Câncer do Estados de São Paulo (ICESP)
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- 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.
- 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.
- 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.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
19. juni 2026
Primær fullføring (Antatt)
1. september 2026
Studiet fullført (Antatt)
1. desember 2026
Datoer for studieregistrering
Først innsendt
2. juni 2026
Først innsendt som oppfylte QC-kriteriene
2. juni 2026
Først lagt ut (Faktiske)
8. juni 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
2. juli 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
1. juli 2026
Sist bekreftet
1. juli 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 5462/2025
- 94890426.9.0000.0068 (Registeridentifikator: Brazilian Ethics Approval (Plataforma Brasil))
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
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, 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.
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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