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OpenTrials
Completed

NCT Number: NCT02136121

Prospective Investigation of Robotic Single-port System

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

Completed

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Key information

Conditions

Prostate and Kidney Cancer Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Neoplasms Male Urogenital Diseases Neoplasms Neoplasms by Site Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Hôpital HURIEZ, CHRU

Lille, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 -

Treatment and study plan

da Vinci Sp Surgical System - Robotic

Device

robotic assisted laparoscopic single-port system

Primary outcomes

  1. To determine the feasibility as measured by the rate of conversions

    Time frame: Intra Operative

    Rate of Conversion to Open approach

Secondary outcomes

  1. 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

  2. Perioperative Surgical outcomes

    Time frame: Intra-operative

    Rate of Transfusion

  3. Perioperative Surgical Outcomes

    Time frame: 30 day, 1 year , 2 year and 3 year follow up

    Procedure specific wound complications , infection

  4. Post-operative - Continence

    Time frame: 1 year, 2 year and 3 year follow up

    Continence measured by use of pads

  5. Perioperative Surgical Outcome- potency

    Time frame: 1 , 2 and 3 year follow up

    Potency rate administered by International Index of Erectile Function patient questionnaire

Sponsors and collaborators

Lead sponsor

Intuitive Surgical

Industry

Registry information

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
May 12, 2014
Registry last updated
May 12, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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