da Vinci SP® Studie av undantag från undersökningsanordningar i kolorektala procedurer
En prospektiv multicenterundersökning av da Vinci SP®-kirurgiska systemet i kolorektala procedurer för godartade och maligna sjukdomar
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.
Studieöversikt
Status
Intervention / Behandling
Detaljerad beskrivning
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
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
Florida
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Orlando, Florida, Förenta staterna, 32803
- Adventist Health System/Sunbelt
-
-
Michigan
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Detroit, Michigan, Förenta staterna, 48202
- Henry Ford
-
-
Minnesota
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Rochester, Minnesota, Förenta staterna, 55905
- Mayo Clinic
-
-
Nevada
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Las Vegas, Nevada, Förenta staterna, 89128
- MountianView Hospital
-
-
Pennsylvania
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Pittsburgh, Pennsylvania, Förenta staterna, 15212
- Allegheny General Hospital
-
-
Texas
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Houston, Texas, Förenta staterna, 77030
- Houston Methodist Research Institute
-
-
Washington
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Tacoma, Washington, Förenta staterna, 98405
- MultiCare - Tacoma
-
-
-
-
Dong-gu
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Ulsan, Dong-gu, Sydkorea, 25 Daehakbyeongwon-ro
- Ulsan University Hospital
-
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Gangseo-gu
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Seoul, Gangseo-gu, Sydkorea, Gonghang-daero
- Ewha Womans University College of Medicine
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Övrig
- Tilldelning: Icke-randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Övrig: 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 |
|
Övrig: 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 |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Rate of Conversion
Tidsram: 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
Tidsram: 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
|
Samarbetspartners och utredare
Sponsor
Utredare
- Studierektor: Madhu L Gorrepati, Clinical Affairs Director
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
- Neoplasmer efter plats
- Neoplasmer
- Tarmsjukdomar
- Gastrointestinala neoplasmer
- Neoplasmer i matsmältningssystemet
- Matsmältningssystemets sjukdomar
- Gastrointestinala sjukdomar
- Intestinala neoplasmer
- Rektala sjukdomar
- Kolonsjukdomar
- Kolorektala neoplasmer
- Kolonneoplasmer
- Kirurgiska ingrepp, operativ
- Teknik, industri och jordbruk
- Automatisering
- Teknologi
- Kirurgi, datorassisterad
- Robotik
- Robotkirurgiska ingrepp
Andra studie-ID-nummer
- dV SP - CR-01
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
Läkemedels- och apparatinformation, studiedokument
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