Clinical trial NCT04403022: da Vinci SP® Investigational Device Exemption Study in Colorectal Procedures
Official title: A Prospective, Multi-Center Investigation of the da Vinci SP® Surgical System in Colorectal Procedures for Benign and Malignant Disease
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Colorectal Cancer
Benign or Malignant Rectal or Colon Tumors
Lead sponsor: Intuitive Surgical
Sponsor class: INDUSTRY
First posted: 2020-05-27
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: 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.

Detailed 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

Eligibility criteria: 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

Primary outcomes:
measure: Performance
timeFrame: IntraOperative period
measure: Adverse Events Rates
timeFrame: Intraoperative through the 42-day postoperative period
Secondary outcomes:
Other outcomes:
Locations:
city: Orlando
country: United States
facility: Adventist Health System/Sunbelt
state: Florida
city: Detroit
country: United States
facility: Henry Ford
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Las Vegas
country: United States
facility: MountianView Hospital
state: Nevada
city: Pittsburgh
country: United States
facility: Allegheny General Hospital
state: Pennsylvania
city: Houston
country: United States
facility: Houston Methodist Research Institute
state: Texas
city: Tacoma
country: United States
facility: MultiCare - Tacoma
state: Washington
city: Ulsan
country: Korea, Republic of
facility: Ulsan University Hospital
state: Dong-gu
city: Seoul
country: Korea, Republic of
facility: Ewha Womans University College of Medicine
state: Gangseo-gu
Study officials:
affiliation: Clinical Affairs Director
name: Madhu L Gorrepati
role: STUDY_DIRECTOR
References: