da Vinci SP® Unntaksstudie for undersøkelsesutstyr i kolorektale prosedyrer
En prospektiv, multi-senter undersøkelse av da Vinci SP® kirurgisk system i kolorektale prosedyrer for godartede og ondartede sykdommer
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.
Studieoversikt
Status
Intervensjon / Behandling
Detaljert 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
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
Florida
-
Orlando, Florida, Forente stater, 32803
- Adventist Health System/Sunbelt
-
-
Michigan
-
Detroit, Michigan, Forente stater, 48202
- Henry Ford
-
-
Minnesota
-
Rochester, Minnesota, Forente stater, 55905
- Mayo Clinic
-
-
Nevada
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Las Vegas, Nevada, Forente stater, 89128
- MountianView Hospital
-
-
Pennsylvania
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Pittsburgh, Pennsylvania, Forente stater, 15212
- Allegheny General Hospital
-
-
Texas
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Houston, Texas, Forente stater, 77030
- Houston Methodist Research Institute
-
-
Washington
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Tacoma, Washington, Forente stater, 98405
- MultiCare - Tacoma
-
-
-
-
Dong-gu
-
Ulsan, Dong-gu, Sør -Korea, 25 Daehakbyeongwon-ro
- Ulsan University Hospital
-
-
Gangseo-gu
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Seoul, Gangseo-gu, Sør -Korea, Gonghang-daero
- Ewha Womans University College of Medicine
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
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 studiet utformet?
Designdetaljer
- Primært formål: Annen
- Tildeling: Ikke-randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Annen: 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 |
|
Annen: 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 |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Studieleder: Madhu L Gorrepati, Clinical Affairs Director
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Neoplasmer etter nettsted
- Neoplasmer
- Tarmsykdommer
- Gastrointestinale neoplasmer
- Neoplasmer i fordøyelsessystemet
- Sykdommer i fordøyelsessystemet
- Gastrointestinale sykdommer
- Intestinale neoplasmer
- Rektale sykdommer
- Kolonsykdommer
- Kolorektale neoplasmer
- Kolon neoplasmer
- Kirurgiske prosedyrer, operativ
- Teknologi, industri og landbruk
- Automasjon
- Teknologi
- Kirurgi, datamaskinassistert
- Robotikk
- Robotkirurgiske inngrep
Andre studie-ID-numre
- dV SP - CR-01
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Legemiddel- og utstyrsinformasjon, studiedokumenter
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