Prospective Investigation of Robotic Single-port System

May 8, 2014 updated by: Intuitive Surgical
To determine the feasibility of representative urologic procedures as measured by the rate of conversions

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

19

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Lille, France
        • Hôpital HURIEZ, CHRU

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 -

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: da Vinci Sp Surgical System
da Vinci Sp Surgical System - Robotic - assisted single-port surgery
Device: da Vinci Sp Surgical System - Robotic
robotic assisted laparoscopic single-port system

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To determine the feasibility as measured by the rate of conversions
Time Frame: Intra Operative
Rate of Conversion to Open approach
Intra Operative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Perioperative surgical outcomes
Time Frame: From admission to discharge from the hospital for the primary procedure typically up to 7 days
Perioperative surgical outcomes length of hospital stay- From admission to discharge from the hospital for the primary procedure
From admission to discharge from the hospital for the primary procedure typically up to 7 days
Perioperative Surgical outcomes
Time Frame: Intra-operative
Rate of Transfusion
Intra-operative
Perioperative Surgical Outcomes
Time Frame: 30 day, 1 year , 2 year and 3 year follow up
Procedure specific wound complications , infection
30 day, 1 year , 2 year and 3 year follow up
Post-operative - Continence
Time Frame: 1 year, 2 year and 3 year follow up
Continence measured by use of pads
1 year, 2 year and 3 year follow up
Perioperative Surgical Outcome- potency
Time Frame: 1 , 2 and 3 year follow up
Potency rate administered by International Index of Erectile Function patient questionnaire
1 , 2 and 3 year follow up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Intuitive Surgical

Investigators

  • Principal Investigator: Arnold Villers, MD, Hôpital HURIEZ, CHRU
  • Study Chair: Jihad Kaouk, MD, The Cleveland Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2010

Primary Completion (Actual)

October 1, 2013

Study Completion (Actual)

October 1, 2013

Study Registration Dates

First Submitted

May 5, 2014

First Submitted That Met QC Criteria

May 8, 2014

First Posted (Estimate)

May 12, 2014

Study Record Updates

Last Update Posted (Estimate)

May 12, 2014

Last Update Submitted That Met QC Criteria

May 8, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 001 (NavyGHB)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Prostate and Kidney Cancer

Clinical Trials on da Vinci Sp Surgical System - Robotic

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Belgium

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe