Safety and Performance Evaluation of the RonovoTM Robotic Surgical Platform in Oncological Procedures (CONSTELAR)
1 juli 2026 uppdaterad 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.
Studieöversikt
Status
Rekrytering
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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
Studietyp
Interventionell
Inskrivning (Beräknad)
40
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Ulysses Ribeiro Júnior, Principal Investigator, MD, Ph
- Telefonnummer: +55 11 3893-3515
- E-post: icesp.pesquisa.np@hc.fm.usp.br
Studieorter
-
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São Paulo
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São Paulo, São Paulo, Brasilien, 05403-010
- Rekrytering
- Instituto do Câncer do Estado de São Paulo - ICESP
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Kontakt:
- Núcleo de Pesquisa Institucional
- Telefonnummer: +55 11 3893-3515
- E-post: icesp.pesquisa.np@hc.fm.usp.br
-
Underutredare:
- Alexandre S e Silva, MD
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Huvudutredare:
- Ulysses Ribeiro Jr, MD, PhD
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Underutredare:
- Carlos FS Marques, MD
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Underutredare:
- Lucas F Sobrado, MD
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Underutredare:
- Ricardo Z Abdalla, MD
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Underutredare:
- Rodrigo J Oliveira, MD
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Underutredare:
- Ricardo M Terra, MD
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Underutredare:
- Pedro HX Nabuco de Araújo, MD
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Underutredare:
- Jesus P Carvalho, MD
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Underutredare:
- Rodrigo P Fernandes, MD
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Underutredare:
- Rodolpho T Kleine, MD
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Underutredare:
- Arnaldo JC Fazoli, MD
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Underutredare:
- Mauricio D Cordeiro, MD
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Underutredare:
- Rafael F Coelho, MD
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Underutredare:
- André R Dias, MD
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Underutredare:
- Gabriel CA Silva, MD
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Underutredare:
- William C Nahas, MD, PhD
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: 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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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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30-day postoperative complication rate (Clavien-Dindo classification)
Tidsram: 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
Tidsram: 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
Tidsram: 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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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Total operative time
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Samarbetspartners
Utredare
- Huvudutredare: Ulysses MD, PhD Ribeiro Jr, Instituto do Câncer do Estados de São Paulo (ICESP)
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Allmänna publikationer
- 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.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
19 juni 2026
Primärt slutförande (Beräknad)
1 september 2026
Avslutad studie (Beräknad)
1 december 2026
Studieregistreringsdatum
Först inskickad
2 juni 2026
Först inskickad som uppfyllde QC-kriterierna
2 juni 2026
Första postat (Faktisk)
8 juni 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
2 juli 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
1 juli 2026
Senast verifierad
1 juli 2026
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 5462/2025
- 94890426.9.0000.0068 (Registeridentifierare: Brazilian Ethics Approval (Plataforma Brasil))
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
IPD-planbeskrivning
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.
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .