NCT05395299

Brief Summary

The aim of this pilot study is to analyze the feasibility of prostatic embolization for the treatment of symptomatic benign prostatic hypertrophy with a non adhesive liquid embolic agent (Squid)

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 29, 2022

Completed
28 days until next milestone

First Posted

Study publicly available on registry

May 27, 2022

Completed
6 months until next milestone

Study Start

First participant enrolled

November 22, 2022

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 22, 2023

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 5, 2024

Completed
Last Updated

February 24, 2025

Status Verified

February 1, 2025

Enrollment Period

1 year

First QC Date

April 29, 2022

Last Update Submit

February 21, 2025

Conditions

Prostatic Hyperplasia, Benign

Outcome Measures

Primary Outcomes (1)

  • The main objective is to study the feasibility of prostate embolization with SQUID

    squid injection success in the prostate assessed by a scanner

    day 0

Secondary Outcomes (1)

  • Description of the causes of technical embolization failures

    day 0

Study Arms (1)

Prostatic Arterial Embolization with SQUID (Ethylene Vinyl Alcohol Copolymer )

EXPERIMENTAL

Injection at the level of the right and left prostate arteries of Squid until a complete occlusion of these arteries, and a filling of their intraprostatic branches

Procedure: SQUID (Ethylene Vinyl Alcohol Copolymer ) administred to the participant with the intervention Prostatic Arterial Embolization

Interventions

SQUID (Ethylene Vinyl Alcohol Copolymer ) administred to the participant with the intervention Prostatic Arterial EmbolizationPROCEDURE

Prostatic Arterial Embolization with SQUID (Ethylene Vinyl Alcohol Copolymer )

Prostatic Arterial Embolization with SQUID (Ethylene Vinyl Alcohol Copolymer )

Eligibility Criteria

Age18 Years - 80 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient over 45 and under 80
  • Benign prostatic hypertrophy with an obstructive syndrome of the lower urinary tract intolerant or refractory to medical treatment (continued for 6 months)
  • Indication of prostatic embolization.
  • Prostate volume of more than 40 ml
  • \- Subject with an IPSS\> 18 and a Qol\> 3
  • Affiliation to a social security scheme.
  • Subject who has given informed consent to participate in the study.

You may not qualify if:

  • patient with neurological bladder or AUS of extra-prostatic origin
  • detrusor dysfunction
  • documented allergy to iodinated contrast media
  • Hepatic insufficiency
  • advanced arteritis
  • severe renal failure with glomerular filtration rate \<60 ml / min / 1.73 m2 body surface area
  • inability to independently complete the self-questionnaires used in the study • acute or chronic prostatitis
  • hydronephrosis
  • diverticulum larger than 2 cm or bladder calculus
  • ureteral stenosis
  • active infectious syndrome
  • Progressive cancer or for which the risk of progressive recovery is more than 50% in the next 5 years
  • limited life expectancy
  • Vulnerable persons defined in Articles L. 1121-5 to L.1121-8 and L.1122-1-2 of the Public Health Code (eg: persons deprived of their liberty, minors, protected adults, etc.)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Nice

Nice, France, 06000, France

Location

Related Publications (2)

  • Sedat J, Fontas E, Arnoffi P, Stranieri G, Colomb F, Chau Y. Prostatic Artery Embolization Using Ethylene Vinyl Alcohol (EVOH) Copolymer for Benign Prostatic Hyperplasia: Twelve-Month Analysis. Cardiovasc Intervent Radiol. 2025 Sep;48(9):1369-1375. doi: 10.1007/s00270-025-04164-x. Epub 2025 Aug 13.

    PMID: 40804546DERIVED

  • Sedat J, Arnoffi P, Poirier F, Jamjoom M, Raffaelli C, Colomb F, Chau Y. Non-target embolic events during prostatic embolization with ethylene vinyl alcohol copolymer (EVOH). CVIR Endovasc. 2023 Nov 3;6(1):54. doi: 10.1186/s42155-023-00402-w.

    PMID: 37922055DERIVED

MeSH Terms

Conditions

Prostatic Hyperplasia

Interventions

ethylene-vinyl alcohol copolymer

Condition Hierarchy (Ancestors)

Prostatic DiseasesGenital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 29, 2022

First Posted

May 27, 2022

Study Start

November 22, 2022

Primary Completion

November 22, 2023

Study Completion

October 5, 2024

Last Updated

February 24, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)