Tests a blood-clotting powder during robotic surgery for prostate cancer
Tests a polysaccharide hemostat to reduce bleeding after prostate removal in men with prostate cancer.
Plain-language title generated from the registry record
Registry title: EFFICACY OF INTRAOPERATIVE ARISTA POLYSACCHARIDE APPLICATION ON THE POSTOPERATIVE BLOOD LOSS IN PATIENTS UNDERGOING RARP FOR THE TREATMENT OF PROSTATE CANCER
Key facts
- Where
- Gronau, Hamburg, and Leipzig, GermanySee the 3 sites
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 45 and 68 years old?
Source: NCT06822036, who can take part
Where in Germany
- St. Antonius-Hospital Gronau GmbH, Klinik für Urologie, Urologische Onkologie und Roboter-assistierte ChirurgieGronau, GermanyTaking people
- Martini Klinik am UKE GmbHHamburg, GermanyTaking people
- Klinik und Poliklinik für Urologie des Universitätsklinikums LeipzigLeipzig, GermanyTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- St. Antonius Hospital Gronau
- Trial code
- NCT06822036
- Record updated
- 29 May 2026
- Original description
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.Read full original descriptionShow less
PROSPECTIVE RANDOMIZED CONTROLLED TRIAL EVALUATING THE EFFICACY OF INTRAOPERATIVE ARISTA™ AH POLYSACCHARIDE APPLICATION ON THE POSTOPERATIVE BLOOD LOSS IN PATIENTS UNDERGOING ROBOTIC ASSISTED RADICAL PROSTATECTOMY FOR THE TREATMENT OF PROSTATE CANCER
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
Inclusion: Age range ≥ 45 to ≥68 yrs; Biopsy proven prostate cancer treated with robotic-assisted radical prostatectomy; Intrafascial nerve sparing surgery (unilaterally or bilaterally); Preoperative urinary continence; Group A Preoperative unassisted International Index of Erectile function (IIEF)-5 score range 8-16 (i.e. moderate (8-11) and mild to moderate (12-16)).
Exclusion: Suspected bone or visceral metastases at preoperative imaging Neoadjuvant androgen deprivation therapy; Any prior local therapy of the prostate (including subvesical deobstruction or radiation therapy); Any prior chemotherapy or colon/rectal surgery; Any prior pelvic trauma that required surgical intervention; Bilateral secondary (complete or partial) resection of the neurovascular bundle; No contraindications for phosphodiesterase type 5 inhibitor intake (i.e. suited for most penile rehabilitation regimes); No surgical revision within 7d after RARP (Clavien Dindo classified complication ≥3b); High risk prostate cancer (PSA ≥ 20 ng/ml or biopsy Gleason-Score ≥ 8 or suspected T4); Depression or other psychological or neurological disease (dementia, schizophrenia, bipolar disorder etc.); Peyronie's disease; Any endocrine function disorder (not including diabetes); SURGICAL AND PERIOPERATIVE EXLUSION CRITERIA:; For a) nerve sparing and b) controlling bleeding in the area of the prostate bed and neurovascular bundles after prostate removal, no monopolar thermal application are allowed but suturing and clip application is allowed. For secondary resection of the neurovascular bundle and controlling bleeding, mono- or bipolar thermal application, clip application and suturing is allowed; Severe intellectual limitations preventing to fully understand the study concept and its content; Polyneuropathia; IPSS Score >19 and QoL >3; Accessory pudendal arteries (APA) preservation, if an APA is identified; No definitive anastomotic partial or complete rupture (identified via cystogram within 30d after RARP).