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EFFICACY OF INTRAOPERATIVE ARISTA POLYSACCHARIDE APPLICATION ON THE POSTOPERATIVE BLOOD LOSS IN PATIENTS UNDERGOING RARP FOR THE TREATMENT OF PROSTATE CANCER
NCT06822036 · St. Antonius Hospital Gronau · Updated 29 May 2026
- What is being tested
- Arm A - Application of 5g of ARISTA™ AH
- For
- Prostate Cancer (Adenocarcinoma); Blood Loss, Postoperative; Erectile Function
- Kind of study
- Tests a treatment or device on volunteers. No drug phase (a device or procedure study).
- Who can join
- Ages 45 years to 68 years. About 362 people. The full rules are on the registry page.
- Where
- Germany (3 sites)
- When
- Starts or started 16 Jan 2025, ends 30 Jan 2027. Registered 12 Feb 2025.
- Results
- None posted yet.
In the researchers' words
We perform a multicenter randomized controlled prospective study with superiority trial design, in which the polysaccharide ARISTA™ AH hemostat agent is applied to the neurovascular bundle areas after prostate removal, during Robot-assisted radical prostatectomy. We examine if such agent leads to a relevant clinical improvement indicated by higher postoperative hemoglobin levels compared to the control group. As an exploratory co-primary endpoint of interest, we examine erectile function after Robot-assisted radical prostatectomy based on IIEF-5 score between groups 3, 6 and 12 months after Robot-assisted radical prostatectomy
Sites
- Martini Klinik am UKE GmbHHamburg, Free and Hanseatic City of Hamburg, Germany
- St. Antonius-Hospital Gronau GmbH, Klinik für Urologie, Urologische Onkologie und Roboter-assistierte ChirurgieGronau, North Rhine-Westphalia, Germany
- Klinik und Poliklinik für Urologie des Universitätsklinikums LeipzigLeipzig, Saxony, Germany