Prospective Investigation of Robotic Single-port System

Intuitive Surgical

Status and phase: Completed; Phase 2; Phase 1

Conditions: Prostate and Kidney Cancer

Treatments: Device: da Vinci Sp Surgical System - Robotic

Study type: Interventional

Funder types: Industry

Identifiers

NCT02136121

001

Details and patient eligibility

About

To determine the feasibility of representative urologic procedures as measured by the rate of conversions

Enrollment: 19 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Prostatectomy:
• Patients age 18-75 years
• BMI <=35 kg/m2
• Confirmed localized adenocarcinoma of the prostate
• Suitable for minimally invasive prostate cancer surgery

Nephrectomy:

• Patient age 18-75 years
• BMI <=35 kg/m2
• Kidney disease amenable to nephrectomy or partial nephrectomy
• Suitable for minimally invasive kidney surgery

Exclusion criteria

Untreated active infection (includes local kidney infection)

• Vulnerable population (ex: prisoners, mentally disabled)
• Severe concomitant illness that drastically shortens life expectancy or increases risk of therapeutic interventions (i.e., cancer)
• Anatomy unsuitable for endoscopic visualization or minimally invasive surgery
• Patient with second primary cancer
• Extensive previous abdominal surgery
• Prior radiation treatment for prostate or kidney cancer
• Patient with distant metastasis
• Complex renal vascular anatomy
• Patient with kidney cancer - stage T3 or N+ M+ **
• Horseshoe kidney**
• Previous ipsilateral kidney surgery **- specific to kidney surgery -

Trial design

19 participants in 1 patient group

da Vinci Sp Surgical System

Experimental group

Description:

da Vinci Sp Surgical System - Robotic - assisted single-port surgery

Treatment:

Device: da Vinci Sp Surgical System - Robotic