da Vinci SP® 결장직장 시술에 대한 조사 기기 면제 연구
양성 및 악성 질환에 대한 결장직장 시술에서 da Vinci SP® 수술 시스템의 전향적 다기관 조사
To confirm the safety and performance of the da Vinci SP Surgical System, Instruments and Accessories in a complex colorectal procedure such as low anterior resections or right colectomy.
연구 개요
상세 설명
Primary Performance:
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The primary performance endpoint will be assessed as the ability to complete the planned da Vinci SP-assisted colorectal procedure without conversion to an alternate approach. Conversion* to an alternate approach comprises conversion to open, multiport laparoscopic**, multiport robotic or hand-assisted§ approach requiring undocking of the da Vinci SP Surgical System in order to complete the planned procedure using the alternate approach.
- Performing an extracorporeal anastomosis is not considered a conversion ** Use of additional assistant laparoscopic port(s) is not considered a conversion § Laparoscopic or robotic with hand assistance
Primary Safety:
• The primary safety endpoint will be assessed as the incidence of all intraoperative and post-operative adverse events that occur through the 42-day follow-up period
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Dong-gu
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Ulsan, Dong-gu, 대한민국, 25 Daehakbyeongwon-ro
- Ulsan University Hospital
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Gangseo-gu
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Seoul, Gangseo-gu, 대한민국, Gonghang-daero
- Ewha Womans University College of Medicine
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Florida
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Orlando, Florida, 미국, 32803
- Adventist Health System/Sunbelt
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Michigan
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Detroit, Michigan, 미국, 48202
- Henry Ford
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Minnesota
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Rochester, Minnesota, 미국, 55905
- Mayo Clinic
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Nevada
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Las Vegas, Nevada, 미국, 89128
- MountianView Hospital
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Pennsylvania
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Pittsburgh, Pennsylvania, 미국, 15212
- Allegheny General Hospital
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Texas
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Houston, Texas, 미국, 77030
- Houston Methodist Research Institute
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Washington
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Tacoma, Washington, 미국, 98405
- MultiCare - Tacoma
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Age ≥ 18 years
- BMI ≤ 35
- Candidate for single-port robotic-assisted surgery for low anterior resection with or without total mesorectal excision or right colectomy procedures
- ASA ≤ 3
- Willing and able to provide a written informed consent document
- Willing and able to comply with the study protocol requirements including perioperative follow-up examinations at 14 days, 42 days post operatively, and post-market long-term follow-up on an annual basis through 5 years
Exclusion Criteria:
- Clinical or radiological evidence of metastatic disease
- Life expectancy less than 6 months
- Cancer of the anal canal requiring an abdominoperineal resection
- Subjects with threatened mesorectal margins (≤1 mm) on MRI or ultrasound (for LAR ONLY)
- Subjects with planned major concomitant procedures (eg. hepatectomaies, other intestinal resections) or emergent case
- Subjects undergoing both LAR/TME and right colectomy during the same operation
- Preoperative colonoscopy demonstrating synchronous colorectal cancer
- History of inflammatory bowel disease
- Subject has a known bleeding or clotting disorder
- Uncontrolled illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- Subject is contraindicated for general anesthesia or surgery
- Subject had prior incisional hernia with mesh repair
- Subject belongs to vulnerable population
- Subject is pregnant or suspected to be pregnant
Intraoperative Exclusion Criteria:
• Subject presents with adhesions or scarring in the pelvis which in the opinion of the investigator limits the ability to perform the minimally invasive procedure
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 다른
- 할당: 무작위화되지 않음
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
다른: SP Lower Anterior Resection
Lower anterior resections (LAR) procedures will performed by da Vinci SP® Surgical System |
da Vinci SP Surgical System, instruments, and accessories in complex colorectal procedures such as low anterior resection procedure or right colectomy with or without total mesorectal excision |
|
다른: SP Right Colectomy
Right Colectomy (RC) procedures performed by da Vinci SP® Surgical System |
da Vinci SP Surgical System, instruments, and accessories in complex colorectal procedures such as low anterior resection procedure or right colectomy with or without total mesorectal excision |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Rate of Conversion
기간: IntraOperative period
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Performance defined as ability to complete the planned da Vinci SP-assisted colorectal procedure without conversion to an alternate approach. |
IntraOperative period
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Major Adverse Events Rates
기간: Intraoperative through the 42-day postoperative period
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Safety defined as the incidence of all major adverse events that occur through the 42-day follow-up period |
Intraoperative through the 42-day postoperative period
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공동 작업자 및 조사자
수사관
- 연구 책임자: Madhu L Gorrepati, Clinical Affairs Director
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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. .