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
Studieöversikt
Status
Betingelser
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Beräknad)
Kontakter och platser
Studieorter
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Ohio
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Columbus, Ohio, Förenta staterna, 43230
- Rekrytering
- Central Ohio Urology Group
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Kontakt:
- Shayna Phillips Research Manager
- Telefonnummer: 614-396-2684
- E-post: shayna.phillips@centralohiourology.com
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
All male patients aged 18 years or older diagnosed with prostate cancer who are treated with robotic surgery using the Hugo™ RAS System.
Beskrivning
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
Hur är studien utformad?
Designdetaljer
- Observationsmodeller: CASE_ONLY
- Tidsperspektiv: PROSPECTIVE
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Incidence of Perioperative Complications
Tidsram: 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
|
|
Incidence of Postoperative Complications
Tidsram: From the end of the procedure through 90 days post-procedure
|
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
Tidsram: 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
|
Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Operative Time
Tidsram: 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
Tidsram: 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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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
|
|
Total Procedure Cost
Tidsram: 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
|
|
Surgeon Learning Curve
Tidsram: From the surgeon's first patient procedure through the last patient procedure
|
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
|
Samarbetspartners och utredare
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Ronney Abaza, MD, Central Ohio Urology Group
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- RAS
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
Läkemedels- och apparatinformation, studiedokument
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