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da Vinci SP® Investigational Device Exemption Study in Colorectal Procedures

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Intuitive Surgical

Status

Active, not recruiting

Conditions

Benign or Malignant Rectal or Colon Tumors
Colorectal Cancer

Treatments

Device: Robotic Assisted Surgery

Study type

Interventional

Funder types

Industry

Identifiers

NCT04403022
dV SP - CR-01

Details and patient eligibility

About

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.

Full description

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

Enrollment

60 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Other

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

60 participants in 1 patient group

Single arm
Other group
Description:
Colorectal procedure will be performed by da Vinci SP® Surgical System
Treatment:
Device: Robotic Assisted Surgery

Trial contacts and locations

9

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Central trial contact

Janet Shelly; Alex Valencia, MS

Data sourced from clinicaltrials.gov

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