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NCT06822036Recruiting

EFFICACY OF INTRAOPERATIVE ARISTA POLYSACCHARIDE APPLICATION ON THE POSTOPERATIVE BLOOD LOSS IN PATIENTS UNDERGOING RARP FOR THE TREATMENT OF PROSTATE CANCER

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

Source: ClinicalTrials.gov · Last updated 29 May 2026

Brief summary (registry, in English)

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

Status (registry)
Recruiting
Study type
Interventional
Enrollment
362 (estimated)
First submitted
6 Feb 2025
Start date
16 Jan 2025
Primary completion date
30 Jan 2027
Lead sponsor
St. Antonius Hospital Gronau
NCT number
NCT06822036

What you commit to

  • Study type: Interventional
  • Planned participants: 362
  • From 16 Jan 2025 to the primary completion date, 30 Jan 2027
  • 3 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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)

Other illness

  • 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.

Other

  • 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)

Who the study is looking for

  • 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))

Age in the registry: 45 years to 68 years · Sex: Male · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (3)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
St. Antonius-Hospital Gronau GmbH, Klinik für Urologie, Urologische Onkologie und Roboter-assistierte Chirurgie
Coordinator of this site? Confirm its status
GronauGermanyRecruiting
Martini Klinik am UKE GmbH
Coordinator of this site? Confirm its status
HamburgGermanyRecruiting
Klinik und Poliklinik für Urologie des Universitätsklinikums Leipzig
Coordinator of this site? Confirm its status
LeipzigGermanyRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.