Prostatectomies Using Einstein Vision® 3D (PROSTEVIS)

January 12, 2021 updated by: Aesculap AG

Prospective, Multi-centre, Non-interventional Trial on Laparoscopic Radical PROSTatectomies Using EinsteinVISion® 3D Visualization System

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

156

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

  • Germany
      • Offenbach, Germany, 63069
        • Sana Klinikum Offenbach
      • Ostfildern, Germany, 73760
        • Medius Klinik Ostfildern-Ruit

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

adult patients

Description

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

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Intraoperatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intraoperative blood loss [ml]
Time Frame: Intraoperatively
Intraoperatively
Intraoperative blood transfusions [quantity]
Time Frame: Intraoperatively
Intraoperatively
Postoperative blood transfusions [quantity]
Time Frame: Postoperatively
Postoperatively
Intraoperative incidence of complications [percentage]
Time Frame: Intraoperatively
(e.g. bleedings, Trauma of ureter)
Intraoperatively
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)
During stay in Hospital (5-12 days postoperatively)
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)
After first intervention for each hospital and after study completion, an average of 1 year later
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
Preoperatively, 5-12 days postoperatively, 3 months, 6 months, 12 months postoperatively
Operation time [min.]
Time Frame: Intraoperatively
Intraoperatively
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
Intraoperatively
Incontinence after catheterization [percentage]
Time Frame: During stay in Hospital (5-12 days postoperatively)
During stay in Hospital (5-12 days postoperatively)
Postoperative hospital stay [days]
Time Frame: During stay in Hospital (5-12 days postoperatively)
During stay in Hospital (5-12 days postoperatively)
Return to erectile function [percentage]
Time Frame: 12 months
12 months
Return to continence function [percentage]
Time Frame: 12 months
12 months
Incontinence pads/pants per day [quantity]
Time Frame: 5-12 days postoperatively, 3 months, 6 months, 12 months postoperatively
5-12 days postoperatively, 3 months, 6 months, 12 months postoperatively
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)
5-12 days postoperatively, 3 months, 6 months, 12 months postoperatively

Collaborators and Investigators

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

Sponsor

Aesculap AG

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 (Actual)

May 19, 2017

Primary Completion (Actual)

December 31, 2019

Study Completion (Actual)

November 6, 2020

Study Registration Dates

First Submitted

December 7, 2016

First Submitted That Met QC Criteria

December 9, 2016

First Posted (Estimate)

December 14, 2016

Study Record Updates

Last Update Posted (Actual)

January 13, 2021

Last Update Submitted That Met QC Criteria

January 12, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AAG-O-H-1607

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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.

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