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
調査の概要
状態
条件
詳細な説明
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.
研究の種類
入学 (推定)
連絡先と場所
研究場所
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Ohio
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Columbus、Ohio、アメリカ、43230
- 募集
- Central Ohio Urology Group
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コンタクト：
- Shayna Phillips Research Manager
- 電話番号：614-396-2684
- メール：shayna.phillips@centralohiourology.com
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
All male patients aged 18 years or older diagnosed with prostate cancer who are treated with robotic surgery using the Hugo™ RAS System.
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 観測モデル：CASE_ONLY
- 時間の展望：PROSPECTIVE
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Incidence of Perioperative Complications
時間枠：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
時間枠：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
時間枠：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
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Operative Time
時間枠：Up to 340 minutes
|
Operative time shall be collected through the length of the procedure. Assessed on the day of surgery |
Up to 340 minutes
|
|
Operating Room Turnover
時間枠：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
|
|
Total Procedure Cost
時間枠：From the date of surgery through completion of associated ambulatory surgical center billing
|
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
時間枠：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
|
協力者と研究者
協力者
捜査官
- 主任研究者：Ronney Abaza, MD、Central Ohio Urology Group
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。