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Prostatectomies Using Einstein Vision® 3D (PROSTEVIS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02991794
Recruitment Status : Active, not recruiting
First Posted : December 14, 2016
Last Update Posted : January 23, 2020
Sponsor:
Information provided by (Responsible Party):
Aesculap AG

Brief Summary:
The aim of the study is collecting clinical data on the learning curve of different surgeons using the EinsteinVision® 3D visualization system in laparoscopic radical prostatectomies.

Condition or disease Intervention/treatment
Prostate Carcinoma Device: EinsteinVision 3D visualization system

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Study Type : Observational
Actual Enrollment : 156 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective, Multi-centre, Non-interventional Trial on Laparoscopic Radical PROSTatectomies Using EinsteinVISion® 3D Visualization System
Actual Study Start Date : May 19, 2017
Actual Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine



Intervention Details:
  • Device: EinsteinVision 3D visualization system
    Elective laparoscopic radical prostatectomy due to histologically proven prostate cancer using EinsteinVision® 3D visualization system.


Primary Outcome Measures :
  1. Time needed to perform the vesicourethral anastomosis using EinsteinVision® in a group of different surgeons [min. sec.] [ Time Frame: Intraoperatively ]
    learning curve of different surgeons with diverse level of experience using EinsteinVision® 3D visualization system


Secondary Outcome Measures :
  1. Intraoperative blood loss [ml] [ Time Frame: Intraoperatively ]
  2. Intraoperative blood transfusions [quantity] [ Time Frame: Intraoperatively ]
  3. Postoperative blood transfusions [quantity] [ Time Frame: Postoperatively ]
  4. Intraoperative incidence of complications [percentage] [ Time Frame: Intraoperatively ]
    (e.g. bleedings, Trauma of ureter)

  5. Postoperative incidence of complications [percentage] [ Time Frame: During stay in Hospital (5-12 days postoperatively) ]
    (e.g. Ileus, venous thrombo-embolic events, wound infection, bleedings)

  6. Surgeon's experience with different operation methods and application systems [ Time Frame: After first intervention for each hospital and after study completion, an average of 1 year later ]
    using a questionnaire at the beginning (First Patient In) and the end of the study (Last Patient In)

  7. Patient's quality of life [ Time Frame: Preoperatively, 5-12 days postoperatively, 3 months, 6 months, 12 months postoperatively ]

    Pre- and postoperative patient's quality of life using the questionnaire EQ-5D-5L

    The following dimensions are assessed:

    • Mobility
    • Self-care
    • Usual activities
    • Pain / discomfort
    • Anxiety / depression
    • Health

  8. Operation time [min.] [ Time Frame: Intraoperatively ]
  9. Intraoperative usability of the device [ Time Frame: Intraoperatively ]

    using a questionnaire containing different dimensions and a 5-point assessment level (Likert Scale: 1 = excellent, 5 = unacceptable).

    The following dimensions are assessed:

    • Control
    • Expenditure of energy
    • Image quality
    • Overall satisfaction

  10. Incontinence after catheterization [percentage] [ Time Frame: During stay in Hospital (5-12 days postoperatively) ]
  11. Postoperative hospital stay [days] [ Time Frame: During stay in Hospital (5-12 days postoperatively) ]
  12. Return to erectile function [percentage] [ Time Frame: 12 months ]
  13. Return to continence function [percentage] [ Time Frame: 12 months ]
  14. Incontinence pads/pants per day [quantity] [ Time Frame: 5-12 days postoperatively, 3 months, 6 months, 12 months postoperatively ]
  15. Postoperative patient satisfaction [ Time Frame: 5-12 days postoperatively, 3 months, 6 months, 12 months postoperatively ]
    using a 10-point assessment level (1 = completely dissatisfied, 10 = completely satisfied)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
adult patients
Criteria

Inclusion Criteria:

  • Patients undergoing planned radical prostatectomy prostatectomy because of histologically proven prostate cancer using EinsteinVision®
  • Written informed consent
  • Age ≥ 18 years

Exclusion Criteria:

  • Previous TURP (= transurethral resection of the prostate)
  • Previous operations on the sigmoid colon or rectum (e.g. because of carcinoma, perforation, diverticulum)
  • BMI > 35 kg/m²
  • Participation in another clinical study
  • Representation by a legal guardian or under involuntary commitment

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02991794


Locations
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Germany
Sana Klinikum Offenbach
Offenbach, Germany, 63069
medius Klinik Ostfildern-Ruit
Ostfildern, Germany, 73760
Sponsors and Collaborators
Aesculap AG
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Responsible Party: Aesculap AG
ClinicalTrials.gov Identifier: NCT02991794    
Other Study ID Numbers: AAG-O-H-1607
First Posted: December 14, 2016    Key Record Dates
Last Update Posted: January 23, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Aesculap AG:
prostatectomy
laparoscopy
3D visualization
learning curve
anastomosis
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases