Prospective Investigation of Robotic Single-port System

• Sponsor: Intuitive Surgical (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02136121
• Collaborator: (none)
• Enrollment: 19
• Location: 1
• Arm: 1
• Duration (Months): 40
• Patients Per Site Per Month: 0.5

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Prostate and Kidney Cancer	Device: da Vinci Sp Surgical System - Robotic	Phase 1/Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 19 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Study Start Date: Jun 1, 2010
• Actual Primary Completion Date: Oct 1, 2013
• Actual Study Completion Date: Oct 1, 2013

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. To determine the feasibility as measured by the rate of conversions [Intra Operative]

   Rate of Conversion to Open approach

Secondary Outcome Measures

1. 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

2. Perioperative Surgical outcomes [Intra-operative]

   Rate of Transfusion

3. Perioperative Surgical Outcomes [30 day, 1 year , 2 year and 3 year follow up]

   Procedure specific wound complications , infection

4. Post-operative - Continence [1 year, 2 year and 3 year follow up]

   Continence measured by use of pads

5. Perioperative Surgical Outcome- potency [1 , 2 and 3 year follow up]

   Potency rate administered by International Index of Erectile Function patient questionnaire

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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 -

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hôpital HURIEZ, CHRU	Lille		France

Sponsors and Collaborators

• Intuitive Surgical

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Intuitive Surgical
• ClinicalTrials.gov Identifier: NCT02136121
• Other Study ID Numbers: 001
• First Posted: May 12, 2014
• Last Update Posted: May 12, 2014
• Last Verified: May 1, 2014

• Additional relevant MeSH terms: Kidney Neoplasms

Study Results

No Results Posted as of May 12, 2014