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
연구 개요
상태
상태
정황
정황
상세 설명
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.
연구 유형
연구 유형
등록 (추정된)
등록
연락처 및 위치
연구 장소
-
-
Ohio
-
Columbus, Ohio, 미국, 43230
- 모병
- Central Ohio Urology Group
-
연락하다:
- Shayna Phillips Research Manager
- 전화번호: 614-396-2684
- 이메일: shayna.phillips@centralohiourology.com
-
-
참여기준
자격 기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
All male patients aged 18 years or older diagnosed with prostate cancer who are treated with robotic surgery using the Hugo™ RAS System.
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 관찰 모델: CASE_ONLY
- 시간 관점: PROSPECTIVE
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Incidence of Perioperative Complications
기간: 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
기간: 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
기간: 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
|
기타 결과 측정
기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Operative Time
기간: 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
기간: 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
기간: 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
기간: 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
|
공동 작업자 및 조사자
수사관
수사관
- 수석 연구원: Ronney Abaza, MD, Central Ohio Urology Group
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
연구 시작
기본 완료 (추정된)
기본 완료
연구 완료 (추정된)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
기타 연구 ID 번호
- RAS
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .