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[Prøvning af enhed, der ikke er godkendt eller godkendt af U.S. FDA]

19. oktober 2026 opdateret af: Medtronic - MITG

This study will evaluate the safety and performance of the Medtronic Hugo™ RAS System when used for urologic RAS procedures.

Studieoversigt

Status

Aktiv, ikke rekrutterende

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

A prospective, multicenter, single-arm pivotal study in subjects undergoing a urologic RAS procedure using the Medtronic Hugo™ RAS System. Subjects without an oncologic indication will be followed for 30 days post-procedure. Oncologic subjects will be followed annually through 5 years. The study will be conducted in up to 6 investigative sites in the United States of America (USA).

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

144

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiesteder

  • Forenede Stater
    • California
      • Duarte, California, Forenede Stater, 91010
        • City of Hope
    • Illinois
      • Chicago, Illinois, Forenede Stater, 60612
        • University of Chiago
    • New York
      • New York, New York, Forenede Stater, 10029
        • Mount Sinai
    • North Carolina
      • Durham, North Carolina, Forenede Stater, 27710
        • Duke Medical Center
    • Ohio
      • Cleveland, Ohio, Forenede Stater, 44195
        • Cleveland Clinic
    • Washington
      • Seattle, Washington, Forenede Stater, 98122
        • Swedish Medical Center

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

22 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  1. Adult subjects (age ≥ 22 years) as required by local law
  2. Subject has been indicated for a radical prostatectomy, radical cystectomy, or nephrectomy (partial or radical) surgical procedure
  3. Subject is an acceptable candidate for a fully robotic assisted surgical procedure, a laparoscopic surgical procedure, or an open surgical procedure
  4. The subject is willing to participate and consents to participate, as documented by a signed and dated informed consent form

Exclusion Criteria:

  1. Subjects for which minimally invasive surgery is contraindicated as determined by the Investigator
  2. Subjects with comorbidities or medical characteristics, which would preclude the surgical procedure in the opinion of the Investigator
  3. Subjects diagnosed with a bleeding disorder and/or cannot be removed from their anticoagulants prior to surgery based on surgeon discretion and standard-of-care
  4. Non-oncology subjects with an estimated life expectancy of less than 6 months; oncology subjects considered for cystectomy with a life expectancy less than 24 months; oncology subjects considered for nephrectomy with a life expectancy less than 60 months; oncology subjects considered for prostatectomy with less than a 10-year life expectancy.
  5. Female subjects pregnant at the time of the surgical procedure.
  6. Subjects who are considered to be part of a vulnerable population (e.g., prisoners or those without sufficient mental capacity)
  7. Subjects who have participated in an investigational drug or device research study within 30 days of enrollment that would interfere with this study
  8. Subjects with active infections including but not limited to pneumonia, urinary tract, cellulitis, or bacteremia

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
Andet: Robotic Assisted Surgery (RAS) Urologic Surgery

Robotic Assisted Surgery (RAS) urologic surgery under the umbrella of procedures outlined by the FDA (prostatectomy, cystectomy and nephrectomy).
Enhed: RAS Prostatectomy

Subjects indicated for Robotic Assisted Surgery (RAS) for prostatectomy will have RAS surgery using the Medtronic Hugo RAS system.

Enhed: RAS Cystectomy

Subjects indicated for Robotic Assisted Surgery (RAS) for cystectomy will have RAS surgery using the Medtronic Hugo RAS system.

Enhed: RAS Nephrectomy

Subjects indicated for Robotic Assisted Surgery (RAS) for nephrectomy (Radical/Partial) will have RAS surgery using the Medtronic Hugo RAS system.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Primary Effectiveness Endpoint - Surgical Success Rate, Defined as the Procedure Not Going Into Conversion
Tidsramme: During surgical procedure

The primary effectiveness endpoint is the surgical success rate, defined as the procedure not going into conversion. Conversion is defined as the switch from a robotic assisted approach using the Hugo system to a robotic assisted approach utilizing an FDA cleared robotic-assisted device, laparoscopic, or open surgery.
During surgical procedure
Primary Safety Endpoint - Rate of Subjects With Complications Meeting Grade III - Grade V Criteria Per the Clavien-Dindo Classification System.
Tidsramme: 30 days

Complications meeting Grade III criteria or higher per the Clavien-Dindo Classification system, from first incision through 30 days post-procedure.

Clavien-Dindo Classification of Surgical Complications:

Grade I: Any deviation from the normal postoperative course without the need for pharmacological treatment or surgical, endoscopic, and radiological interventions.

Grade II: Requiring pharmacological treatment with drugs other than such allowed for grade I complications. Blood transfusions and total parenteral nutrition are also included.

Grade III: Requiring surgical, endoscopic or radiological intervention Grade IIIa: Intervention not under general anesthesia Grade IIIb: Intervention under general anesthesia Grade IV: Life-threatening complication requiring IC/ICU management Grade IVa: Single organ dysfunction (including dialysis) Grade IVb: Multiorgan dysfunction Grade V: Death of a patient
30 days

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Secondary Endpoint - Overall Complication Rate From First Incision Through 30 Days Post-procedure.
Tidsramme: 30 days

Complication rate: Overall rate of subjects with one or more complications (Clavien-Dindo Grade I or higher), from the first incision through 30 days post-procedure.
30 days
Secondary Endpoint - Operative Time (Min)
Tidsramme: up to 720 minutes

Operative time shall be collected through the length of the procedure.
up to 720 minutes
Secondary Endpoint - Intraoperative Estimated Blood Loss (mL).
Tidsramme: intraoperative

Intraoperative estimated blood loss shall be collected through the length of the procedure.
intraoperative
Secondary Endpoint - Transfusion Rate Through 30 Days.
Tidsramme: 30 days

Transfusion rate shall be collected through 30 days post-procedure
30 days
Secondary Endpoint - Rate of Device-related Conversions
Tidsramme: intraoperative

Rate of device-related conversions shall be collected through the length of the procedure.
intraoperative
Secondary Endpoint - Hospital Length of Stay (Days)
Tidsramme: 30 days

Hospital length of stay (days) shall be collected through 30 days post-procedure.
30 days
Secondary Endpoint - Readmission Rate (Through 30 Days)
Tidsramme: 30 days

Readmission rate shall be collected though 30 days post-procedure.
30 days
Secondary Endpoint - Reoperation Rate (Through 30 Days).
Tidsramme: 30 days

Reoperation rate shall be collected through 30 days post-procedure.
30 days
Secondary Endpoint - Mortality Rate (Through 30 Days).
Tidsramme: 30 days

Mortality rate shall be collected through 30 days post-procedure.
30 days
Secondary Endpoint - Progression-free Survival
Tidsramme: 5 years

Progression-free survival rate will be assessed through 5 years in oncologic subjects.
5 years
Secondary Endpoint - Disease-free Survival
Tidsramme: 5 years

Disease-free survival rate will be assessed through 5 years in oncologic subjects.
5 years
Secondary Endpoint - Overall Survival
Tidsramme: 5 years

Overall survival rate will be assessed through 5 years in oncologic subjects.
5 years

Samarbejdspartnere og efterforskere

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

Sponsor

Medtronic - MITG

Efterforskere

  • Studiestol: Michael Abern, MD, Duke Medical Center

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 (Faktiske)

14. december 2022

Primær færdiggørelse (Faktiske)

10. oktober 2024

Studieafslutning (Anslået)

31. januar 2030

Datoer for studieregistrering

Først indsendt

18. november 2022

Først indsendt, der opfyldte QC-kriterier

23. januar 2023

Først opslået (Faktiske)

25. januar 2023

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

3. november 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

19. oktober 2026

Sidst verificeret

1. oktober 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • MDT19051EINURO

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ja

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