da Vinci SP® Investigational Device Exemption Study in Colorectal Procedures

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