【米国FDAの承認・認可を受けていない機器のトライアル】
This study will evaluate the safety and performance of the Medtronic Hugo™ RAS System when used for urologic RAS procedures.
調査の概要
状態
詳細な説明
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).
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
-
-
California
-
Duarte、California、アメリカ、91010
- City of Hope
-
-
Illinois
-
Chicago、Illinois、アメリカ、60612
- University of Chiago
-
-
New York
-
New York、New York、アメリカ、10029
- Mount Sinai
-
-
North Carolina
-
Durham、North Carolina、アメリカ、27710
- Duke Medical Center
-
-
Ohio
-
Cleveland、Ohio、アメリカ、44195
- Cleveland Clinic
-
-
Washington
-
Seattle、Washington、アメリカ、98122
- Swedish Medical Center
-
-
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
説明
Inclusion Criteria:
- Adult subjects (age ≥ 22 years) as required by local law
- Subject has been indicated for a radical prostatectomy, radical cystectomy, or nephrectomy (partial or radical) surgical procedure
- Subject is an acceptable candidate for a fully robotic assisted surgical procedure, a laparoscopic surgical procedure, or an open surgical procedure
- The subject is willing to participate and consents to participate, as documented by a signed and dated informed consent form
Exclusion Criteria:
- Subjects for which minimally invasive surgery is contraindicated as determined by the Investigator
- Subjects with comorbidities or medical characteristics, which would preclude the surgical procedure in the opinion of the Investigator
- 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
- 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.
- Female subjects pregnant at the time of the surgical procedure.
- Subjects who are considered to be part of a vulnerable population (e.g., prisoners or those without sufficient mental capacity)
- Subjects who have participated in an investigational drug or device research study within 30 days of enrollment that would interfere with this study
- Subjects with active infections including but not limited to pneumonia, urinary tract, cellulitis, or bacteremia
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
- 主な目的：処理
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
他の：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). |
Subjects indicated for Robotic Assisted Surgery (RAS) for prostatectomy will have RAS surgery using the Medtronic Hugo RAS system. Subjects indicated for Robotic Assisted Surgery (RAS) for cystectomy will have RAS surgery using the Medtronic Hugo RAS system. Subjects indicated for Robotic Assisted Surgery (RAS) for nephrectomy (Radical/Partial) will have RAS surgery using the Medtronic Hugo RAS system. |
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 |
|---|---|---|
|
Primary Effectiveness Endpoint - Surgical Success Rate, Defined as the Procedure Not Going Into Conversion
時間枠：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.
時間枠：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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Secondary Endpoint - Overall Complication Rate From First Incision Through 30 Days Post-procedure.
時間枠：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)
時間枠：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).
時間枠：intraoperative
|
Intraoperative estimated blood loss shall be collected through the length of the procedure. |
intraoperative
|
|
Secondary Endpoint - Transfusion Rate Through 30 Days.
時間枠：30 days
|
Transfusion rate shall be collected through 30 days post-procedure |
30 days
|
|
Secondary Endpoint - Rate of Device-related Conversions
時間枠：intraoperative
|
Rate of device-related conversions shall be collected through the length of the procedure. |
intraoperative
|
|
Secondary Endpoint - Hospital Length of Stay (Days)
時間枠：30 days
|
Hospital length of stay (days) shall be collected through 30 days post-procedure. |
30 days
|
|
Secondary Endpoint - Readmission Rate (Through 30 Days)
時間枠：30 days
|
Readmission rate shall be collected though 30 days post-procedure. |
30 days
|
|
Secondary Endpoint - Reoperation Rate (Through 30 Days).
時間枠：30 days
|
Reoperation rate shall be collected through 30 days post-procedure. |
30 days
|
|
Secondary Endpoint - Mortality Rate (Through 30 Days).
時間枠：30 days
|
Mortality rate shall be collected through 30 days post-procedure. |
30 days
|
|
Secondary Endpoint - Progression-free Survival
時間枠：5 years
|
Progression-free survival rate will be assessed through 5 years in oncologic subjects. |
5 years
|
|
Secondary Endpoint - Disease-free Survival
時間枠：5 years
|
Disease-free survival rate will be assessed through 5 years in oncologic subjects. |
5 years
|
|
Secondary Endpoint - Overall Survival
時間枠：5 years
|
Overall survival rate will be assessed through 5 years in oncologic subjects. |
5 years
|
協力者と研究者
スポンサー
捜査官
- スタディチェア：Michael Abern, MD、Duke Medical Center
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
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
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- MDT19051EINURO
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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