Prostate CarcinomaPROSTEVISNCT02991794
Prostatectomies Using Einstein Vision® 3D
An observational study of Prostate Carcinoma, run by Aesculap AG at 2 sites in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Carcinoma
- What is being tested?
- EinsteinVision 3D visualization system
- Type of treatment
- Medical device
- How many people
- 156 participants
- Where
- 2 sitesGermany
- Study dates
- 19 May 2017to 6 Nov 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: adult patients
Who may be able to join
- Patients undergoing planned radical prostatectomy prostatectomy because of histologically proven prostate cancer using EinsteinVision®
- Written informed consent
- Age ≥ 18 years
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
Sana Klinikum Offenbach
Offenbach, 63069
medius Klinik Ostfildern-Ruit
Ostfildern, 73760
About this study
Official title: 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.
- Conditions
- Prostate Carcinoma
- Being tested
- EinsteinVision 3D visualization system
- Keywords
- prostatectomy, laparoscopy, 3D visualization, learning curve, anastomosis
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EinsteinVision 3D visualization systemDevice
Elective laparoscopic radical prostatectomy due to histologically proven prostate cancer using EinsteinVision® 3D visualization system.
What is being measured
The primary outcome is the main question the study is designed to answer.
Time needed to perform the vesicourethral anastomosis using EinsteinVision® in a group of different surgeons [min. sec.]
learning curve of different surgeons with diverse level of experience using EinsteinVision® 3D visualization system
Measured: Intraoperatively
Secondary outcomes (15)
Intraoperative blood loss [ml]
Measured: Intraoperatively
Intraoperative blood transfusions [quantity]
Measured: Intraoperatively
Postoperative blood transfusions [quantity]
Measured: Postoperatively
Intraoperative incidence of complications [percentage]
(e.g. bleedings, Trauma of ureter)
Measured: Intraoperatively
Postoperative incidence of complications [percentage]
(e.g. Ileus, venous thrombo-embolic events, wound infection, bleedings)
Measured: During stay in Hospital (5-12 days postoperatively)
Surgeon's experience with different operation methods and application systems
using a questionnaire at the beginning (First Patient In) and the end of the study (Last Patient In)
Measured: After first intervention for each hospital and after study completion, an average of 1 year later
Patient's quality of life
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
Measured: Preoperatively, 5-12 days postoperatively, 3 months, 6 months, 12 months postoperatively
Operation time [min.]
Measured: Intraoperatively
Intraoperative usability of the device
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
Measured: Intraoperatively
Incontinence after catheterization [percentage]
Measured: During stay in Hospital (5-12 days postoperatively)
Postoperative hospital stay [days]
Measured: During stay in Hospital (5-12 days postoperatively)
Return to erectile function [percentage]
Measured: 12 months
Return to continence function [percentage]
Measured: 12 months
Incontinence pads/pants per day [quantity]
Measured: 5-12 days postoperatively, 3 months, 6 months, 12 months postoperatively
Postoperative patient satisfaction
using a 10-point assessment level (1 = completely dissatisfied, 10 = completely satisfied)
Measured: 5-12 days postoperatively, 3 months, 6 months, 12 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2016 (estimated)
- Study start19 May 2017
- Primary completion31 Dec 2019
- Study completion6 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 156 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aesculap AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02991794
- Sponsor's protocol ID
- AAG-O-H-1607
- Acronym
- PROSTEVIS
- Status last verified
- Jan 2021
- First submitted
- 7 Dec 2016
- Last updated
- 13 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Multi-centre, Non-interventional Trial on Laparoscopic Radical PROSTatectomies Using EinsteinVISion® 3D Visualization System
- ClinicalTrials.gov ID
- NCT02991794
- Acronym / sponsor ID
- PROSTEVIS / AAG-O-H-1607
- Conditions
- Prostate Carcinoma
- Keywords
- prostatectomy, laparoscopy, 3D visualization, learning curve, anastomosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 156 participants (actual)
- Lead sponsor
- Aesculap AGIndustry (pharma, biotech, devices)
- Study start
- 19 May 2017 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 6 Nov 2020 (actual)
- First posted
- 14 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- adult patients
Key inclusion criteria (3 listed)
- Patients undergoing planned radical prostatectomy prostatectomy because of histologically proven prostate cancer using EinsteinVision®
- Written informed consent
- Age ≥ 18 years
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EinsteinVision 3D visualization systemElective laparoscopic radical prostatectomy due to histologically proven prostate cancer using EinsteinVision® 3D visualization system. | Device | – |
Primary outcome
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
15 secondary outcomes
Intraoperative blood loss [ml]
Time frame: Intraoperatively
Intraoperative blood transfusions [quantity]
Time frame: Intraoperatively
Postoperative blood transfusions [quantity]
Time frame: Postoperatively
Intraoperative incidence of complications [percentage]
Time frame: Intraoperatively
Postoperative incidence of complications [percentage]
Time frame: 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
Patient's quality of life
Time frame: Preoperatively, 5-12 days postoperatively, 3 months, 6 months, 12 months postoperatively
Operation time [min.]
Time frame: Intraoperatively
Intraoperative usability of the device
Time frame: Intraoperatively
Incontinence after catheterization [percentage]
Time frame: During stay in Hospital (5-12 days postoperatively)
Postoperative hospital stay [days]
Time frame: During stay in Hospital (5-12 days postoperatively)
Return to erectile function [percentage]
Time frame: 12 months
Return to continence function [percentage]
Time frame: 12 months
Incontinence pads/pants per day [quantity]
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Carcinoma, run by Aesculap AG at 2 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time needed to perform the vesicourethral anastomosis using EinsteinVision® in a group of different surgeons [min. sec.] (time frame: Intraoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2021.