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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 19, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 6, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 7, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 9, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 14, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 13, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 12, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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