Prospective Investigation of Robotic Single-port System

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-06-30

Study Completion Date

2013-10-31

Brief Summary

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

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Detailed Description

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Conditions

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Prostate and Kidney Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Study Groups

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da Vinci Sp Surgical System

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

Group Type EXPERIMENTAL

da Vinci Sp Surgical System - Robotic

Intervention Type DEVICE

robotic assisted laparoscopic single-port system

Interventions

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da Vinci Sp Surgical System - Robotic

robotic assisted laparoscopic single-port system

Intervention Type DEVICE

Eligibility Criteria

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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 -

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No