Prostatectomies Using Einstein Vision® 3D

Prostate Carcinoma Clinical Trial

— PROSTEVIS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02991794
• Other study ID #: AAG-O-H-1607
• Status: Completed
• Start date: May 19, 2017
• Est. completion date: November 6, 2020

Study information

• Verified date: January 2021
• Source: Aesculap AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 156
• Est. completion date: November 6, 2020
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prostate Carcinoma
• Prostatic Neoplasms

Intervention

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

Locations

Country	Name	City	State
Germany	Sana Klinikum Offenbach	Offenbach
Germany	medius Klinik Ostfildern-Ruit	Ostfildern

Sponsors (1)

Lead Sponsor	Collaborator
Aesculap AG

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Intraoperatively
Secondary	Intraoperative blood loss [ml]		Intraoperatively
Secondary	Intraoperative blood transfusions [quantity]		Intraoperatively
Secondary	Postoperative blood transfusions [quantity]		Postoperatively
Secondary	Intraoperative incidence of complications [percentage]	(e.g. bleedings, Trauma of ureter)	Intraoperatively
Secondary	Postoperative incidence of complications [percentage]	(e.g. Ileus, venous thrombo-embolic events, wound infection, bleedings)	During stay in Hospital (5-12 days postoperatively)
Secondary	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)	After first intervention for each hospital and after study completion, an average of 1 year later
Secondary	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	Preoperatively, 5-12 days postoperatively, 3 months, 6 months, 12 months postoperatively
Secondary	Operation time [min.]		Intraoperatively
Secondary	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	Intraoperatively
Secondary	Incontinence after catheterization [percentage]		During stay in Hospital (5-12 days postoperatively)
Secondary	Postoperative hospital stay [days]		During stay in Hospital (5-12 days postoperatively)
Secondary	Return to erectile function [percentage]		12 months
Secondary	Return to continence function [percentage]		12 months
Secondary	Incontinence pads/pants per day [quantity]		5-12 days postoperatively, 3 months, 6 months, 12 months postoperatively
Secondary	Postoperative patient satisfaction	using a 10-point assessment level (1 = completely dissatisfied, 10 = completely satisfied)	5-12 days postoperatively, 3 months, 6 months, 12 months postoperatively