da Vinci SP® undersøgelse af fritagelse for undersøgelsesanordninger i kolorektale procedurer
En prospektiv, multi-center undersøgelse af da Vinci SP® kirurgiske system i kolorektale procedurer for godartede og ondartede sygdomme
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.
Studieoversigt
Status
Intervention / Behandling
Detaljeret beskrivelse
Primary Performance:
-
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
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
Florida
-
Orlando, Florida, Forenede Stater, 32803
- Adventist Health System/Sunbelt
-
-
Michigan
-
Detroit, Michigan, Forenede Stater, 48202
- Henry Ford
-
-
Minnesota
-
Rochester, Minnesota, Forenede Stater, 55905
- Mayo Clinic
-
-
Nevada
-
Las Vegas, Nevada, Forenede Stater, 89128
- MountianView Hospital
-
-
Pennsylvania
-
Pittsburgh, Pennsylvania, Forenede Stater, 15212
- Allegheny General Hospital
-
-
Texas
-
Houston, Texas, Forenede Stater, 77030
- Houston Methodist Research Institute
-
-
Washington
-
Tacoma, Washington, Forenede Stater, 98405
- MultiCare - Tacoma
-
-
-
-
Dong-gu
-
Ulsan, Dong-gu, Sydkorea, 25 Daehakbyeongwon-ro
- Ulsan University Hospital
-
-
Gangseo-gu
-
Seoul, Gangseo-gu, Sydkorea, Gonghang-daero
- Ewha Womans University College of Medicine
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Andet
- Tildeling: Ikke-randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Andet: 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 |
|
Andet: 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 |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Rate of Conversion
Tidsramme: IntraOperative period
|
Performance defined as ability to complete the planned da Vinci SP-assisted colorectal procedure without conversion to an alternate approach. |
IntraOperative period
|
|
Major Adverse Events Rates
Tidsramme: Intraoperative through the 42-day postoperative period
|
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
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Studieleder: Madhu L Gorrepati, Clinical Affairs Director
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Neoplasmer efter sted
- Neoplasmer
- Tarmsygdomme
- Gastrointestinale neoplasmer
- Neoplasmer i fordøjelsessystemet
- Sygdomme i fordøjelsessystemet
- Gastrointestinale sygdomme
- Intestinale neoplasmer
- Endetarmssygdomme
- Tyktarmssygdomme
- Kolorektale neoplasmer
- Colon neoplasmer
- Kirurgiske procedurer, operative
- Teknologi, industri og landbrug
- Automatisering
- Teknologi
- Kirurgi, computerassisteret
- Robotik
- Robotkirurgiske procedurer
Andre undersøgelses-id-numre
- dV SP - CR-01
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
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