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NCT05389202Completed

Study of Prostate Perfusion Before Embolization in Patients With Symptomatic Prostate Adenoma

Study of Prostate Perfusion Before Embolization in Patients With Symptomatic Prostate Adenoma. A Single-center Prospective Cohort Pilot Study to Determine the Predictive Factors of Clinical Efficacy Associated With a Prior Phantom Study.

Source: ClinicalTrials.gov · Last updated 10 Mar 2025

Brief summary (registry, in English)

Over the last 5 years, prostate embolization has developed as a treatment for symptomatic prostate adenoma. This long, complex procedure is effective in 80% of cases. Currently there are no means of better selecting patients to avoid this long procedure in non-responders. The hypothesis is that prostate perfusion parameters are correlated with the efficacy of embolization. Studying these prostate perfusion parameters in perfusion CT and evaluating prostate Iodine load in dual energy computed tomography will make it easier to select those patients who are most likely to respond.

Status (registry)
Completed
Study type
Interventional
Enrollment
45 (actual)
First submitted
11 May 2022
Start date
12 May 2022
Primary completion date
19 Jan 2024
Lead sponsor
Centre Hospitalier Universitaire de Nīmes
NCT number
NCT05389202

What you commit to

  • Study type: Interventional
  • Participants enrolled: 45
  • From 12 May 2022 to the primary completion date, 19 Jan 2024
  • 1 site 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.

Other illness

  • Hypersensitivity to the active substance or to one of the excipients of the iodized contrast medium.
  • Severe renal impairment with renal function \<30mL/min.

Other

  • Contraindication to prostate embolization (aorto-iliac bypass)
  • Patient participating in research defined as Category 1 Research Involving Human Subjects.
  • Patient in an exclusion period as determined by another study.
  • Patient under court protection, guardianship or curatorship.
  • Patient unable to give consent.
  • Patient for whom it is impossible to give informed information.

Who the study is looking for

  • Patients with symptomatic benign prostatic hypertrophy (prostate volume \> 50, IPSS \>7, QoL\>2) or patients catheterized after acute retention of urine with failed catheterization.
  • Creatinine clearance \> 30 mL/min for one of the two Cockcroft-Gault/MDRD equations)
  • Adult patients (≥18 years).
  • Patients with an indication for prostate embolization.
  • Patient with free and informed consent.
  • Patient who have signed the consent form.
  • Patient affiliated or beneficiary of a health insurance plan.

Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Nîmes University Hospital
Coordinator of this site? Confirm its status
NîmesFranceUnknown status

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