Prospective Investigation of Robotic Single-port System

Phase 1

Completed

• Conditions: Prostate and Kidney Cancer
• Interventions: Device: da Vinci Sp Surgical System - Robotic

• Registration Number: NCT02136121
• Lead Sponsor: Intuitive Surgical

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2010-06
• Primary Completion: 2013-10
• Study Completion: 2013-10
• Status Verified: 2014-05
• Study First Submitted: 2014-05-05
• Study First Submitted QC: 2014-05-08
• Last Update Submitted: 2014-05-08
• Study First Posted: 2014-05-12
• Last Update Posted: 2014-05-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

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

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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 -

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
da Vinci Sp Surgical System	da Vinci Sp Surgical System - Robotic	da Vinci Sp Surgical System - Robotic - assisted single-port surgery

Primary Outcome Measures

Name	Time	Method
To determine the feasibility as measured by the rate of conversions	Intra Operative	Rate of Conversion to Open approach

Secondary Outcome Measures

Name	Time	Method
Perioperative surgical outcomes	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
Perioperative Surgical outcomes	Intra-operative	Rate of Transfusion
Perioperative Surgical Outcomes	30 day, 1 year , 2 year and 3 year follow up	Procedure specific wound complications , infection
Post-operative - Continence	1 year, 2 year and 3 year follow up	Continence measured by use of pads
Perioperative Surgical Outcome- potency	1 , 2 and 3 year follow up	Potency rate administered by International Index of Erectile Function patient questionnaire

Trial Locations

Locations (1)

Hôpital HURIEZ, CHRU; 🇫🇷 Lille, France