Hugo™ Robotic Assisted Surgery (RAS) System in Prostatectomy Patients Treated in an ASC Setting
A Single-center Study of Robotic Prostatectomy Surgeries Performed Using the Medtronic Hugo™ Robotic Assisted Surgery (RAS) System in an Ambulatory Surgical Center Setting
A Single-center Study of Robotic Prostatectomy Surgeries Performed using the Medtronic Hugo™ Robotic Assisted Surgery (RAS) System in an Ambulatory Surgical Center Setting
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
The purpose of this study is to collect and analyze clinical, procedural/operational and economics data on the commercial use of the Hugo™ Robotic Assisted Surgery (RAS) System in prostatectomy patients treated in an ASC setting at the Central Ohio Urology Group (COUG).
This data will address a current evidence gap by providing insights into clinical outcomes, learning curve, procedural efficiency, patient recovery, and economic metrics at COUG. The study also aims to demonstrate the feasibility and benefits of performing RAS in an ASC setting, thereby advancing the adoption of Hugo™ RAS in this growing care setting.
Undersøgelsestype
Tilmelding (Anslået)
Kontakter og lokationer
Studiesteder
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Ohio
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Columbus, Ohio, Forenede Stater, 43230
- Rekruttering
- Central Ohio Urology Group
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Kontakt:
- Shayna Phillips Research Manager
- Telefonnummer: 614-396-2684
- E-mail: shayna.phillips@centralohiourology.com
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
All male patients aged 18 years or older diagnosed with prostate cancer who are treated with robotic surgery using the Hugo™ RAS System.
Beskrivelse
Inclusion Criteria:
- Subjects (male) ≥ 18 years old
- Subject has been indicated for a radical prostatectomy surgical procedure
- Subject is able to be treated with robotic surgery
- Subject is willing to participate and consents to participate, as documented by signed Institutional Review Board (IRB) approved informed consent form
Exclusion Criteria:
- Contraindicated for treatment with the Hugo™ RAS System in accordance with the commercial Instructions for Use and local regulations
- Subject is participating in another clinical investigation at the time of enrollment or has planned participation in another clinical investigation at any time during this study that may influence the results of this study
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Observationsmodeller: CASE_ONLY
- Tidsperspektiver: PROSPECTIVE
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Incidence of Perioperative Complications
Tidsramme: From first incision through skin closure
|
Number of participants experiencing an intraoperative complication following robot-assisted radical prostatectomy performed using the Hugo™ RAS System. Complications will be classified according to institutional standards and summarized by severity. |
From first incision through skin closure
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|
Incidence of Postoperative Complications
Tidsramme: From the end of the procedure through 90 days post-procedure
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Number of participants experiencing a postoperative complication following robot-assisted radical prostatectomy performed using the Hugo™ RAS System. Complications will be classified according to institutional standards and summarized by severity. |
From the end of the procedure through 90 days post-procedure
|
|
Conversion to Alternative Surgical Approach
Tidsramme: From first incision through skin closure
|
Number of procedures converted from robotic-assisted surgery using the Hugo™ RAS System to an open, laparoscopic, or other surgical approach. |
From first incision through skin closure
|
Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Operative Time
Tidsramme: Up to 340 minutes
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Operative time shall be collected through the length of the procedure. Assessed on the day of surgery |
Up to 340 minutes
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Operating Room Turnover
Tidsramme: From completion of the procedure (skin closure) until operating room readiness for the subsequent case, assessed on the day of surgery
|
Time from completion of a procedure until the operating room is ready for the subsequent case |
From completion of the procedure (skin closure) until operating room readiness for the subsequent case, assessed on the day of surgery
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|
Total Procedure Cost
Tidsramme: From the date of surgery through completion of associated ambulatory surgical center billing
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Total direct Ambulatory Surgery Center cost associated with robot-assisted radical prostatectomy performed using the Hugo™ RAS System |
From the date of surgery through completion of associated ambulatory surgical center billing
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|
Surgeon Learning Curve
Tidsramme: From the surgeon's first patient procedure through the last patient procedure
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Change in operative time across sequential prostatectomy cases performed using the Hugo™ RAS System as a measure of surgeon proficiency acquisition |
From the surgeon's first patient procedure through the last patient procedure
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Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Ronney Abaza, MD, Central Ohio Urology Group
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- RAS
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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