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[Prøving av enhet som ikke er godkjent eller godkjent av U.S. FDA]

19. oktober 2026 oppdatert av: Medtronic - MITG

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

Studieoversikt

Status

Aktiv, ikke rekrutterende

Forhold

Intervensjon / Behandling

Detaljert 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).

Studietype

Intervensjonell

Registrering (Faktiske)

144

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

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

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

22 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

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

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
Annen: 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).
Enhet: RAS Prostatectomy

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

Enhet: RAS Cystectomy

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

Enhet: RAS Nephrectomy

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

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Medtronic - MITG

Etterforskere

  • Studiestol: Michael Abern, MD, Duke Medical Center

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

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)

14. desember 2022

Primær fullføring (Faktiske)

10. oktober 2024

Studiet fullført (Antatt)

31. januar 2030

Datoer for studieregistrering

Først innsendt

18. november 2022

Først innsendt som oppfylte QC-kriteriene

23. januar 2023

Først lagt ut (Faktiske)

25. januar 2023

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

3. november 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

19. oktober 2026

Sist bekreftet

1. oktober 2026

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • MDT19051EINURO

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Ja

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