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Prostatic Arterial Embolization With SQUID (Ethylene Vinyl Alcohol Copolymer ) (SQUID)

Primary Purpose

Prostatic Hyperplasia, Benign

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
SQUID (Ethylene Vinyl Alcohol Copolymer ) administred to the participant with the intervention Prostatic Arterial Embolization
Sponsored by
Centre Hospitalier Universitaire de Nice
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostatic Hyperplasia, Benign

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria

  • 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.

Exclusion criteria patient with prostate cancer or suspected of having prostate cancer

  • 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
  • major surgery in the four months preceding the inclusion visit
  • 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.)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Prostatic Arterial Embolization with SQUID (Ethylene Vinyl Alcohol Copolymer )

    Arm Description

    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

    Outcomes

    Primary Outcome Measures

    The main objective is to study the feasibility of prostate embolization with SQUID
    squid injection success in the prostate assessed by a scanner

    Secondary Outcome Measures

    Description of the causes of technical embolization failures
    Injection into the 2 prostate lobes

    Full Information

    First Posted
    April 29, 2022
    Last Updated
    May 24, 2022
    Sponsor
    Centre Hospitalier Universitaire de Nice
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05395299
    Brief Title
    Prostatic Arterial Embolization With SQUID (Ethylene Vinyl Alcohol Copolymer )
    Acronym
    SQUID
    Official Title
    Feasibility of Prostatic Arterial Embolization With SQUID (Ethylene Vinyl Alcohol Copolymer ) in Symptomatic Patients With Benign Prostatic Hyperplasia: Monocentric Pilot Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    June 1, 2022 (Anticipated)
    Primary Completion Date
    June 1, 2024 (Anticipated)
    Study Completion Date
    June 1, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Centre Hospitalier Universitaire de Nice

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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)
    Detailed Description
    Microparticle prostatic embolization is an effective technique in the short and medium term in the treatment of symptoms related to benign prostatic hyperplasia. If this technique allows an improvement of the patients' symptoms, and fewer operative complications than urological interventions, on the other hand, the injection of arterial particles has several disadvantages: a random long-term durability mainly due to a revascularization of the embolized territories ; inferiority compared to urological treatments in terms of reduction of prostate volume and improvement of postoperative urodynamic tests; poor visualization of the embolization material, and a risk of injection of the particles into an artery supplying a non-target organ. Ethylene vinyl alcohol copolymer is a liquid embolism used for the endovascular treatment of cerebral arteriovenous malformations since 2005 and in specific extracerebral applications due to its advantageous physical properties (its viscous nature, its slow polymerization, its definitive and very distal occlusion, and its high fluoroscopic visibility). These properties would allow in prostatic embolization: to obtain better control during the injection and therefore to improve the safety of the embolization; to reduce the risk of recurrence; and to achieve a more intense prostatic ischemia and therefore to obtain a greater reduction in prostatic volume, and a better improvement in urodynamic tests. The aim of this pilot study is to analyze the feasibility of injecting this liquid embolic agent during the endovascular treatment of symptomatic benign prostatic hypertrophy. If this preliminary study is positive, a randomized phase III study could be undertaken to judge the results and the place of this technique in the treatment of symptoms related to benign prostatic hyperplasia.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Prostatic Hyperplasia, Benign

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    10 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Prostatic Arterial Embolization with SQUID (Ethylene Vinyl Alcohol Copolymer )
    Arm Type
    Experimental
    Arm Description
    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
    Intervention Type
    Procedure
    Intervention Name(s)
    SQUID (Ethylene Vinyl Alcohol Copolymer ) administred to the participant with the intervention Prostatic Arterial Embolization
    Intervention Description
    Prostatic Arterial Embolization with SQUID (Ethylene Vinyl Alcohol Copolymer )
    Primary Outcome Measure Information:
    Title
    The main objective is to study the feasibility of prostate embolization with SQUID
    Description
    squid injection success in the prostate assessed by a scanner
    Time Frame
    day 0
    Secondary Outcome Measure Information:
    Title
    Description of the causes of technical embolization failures
    Description
    Injection into the 2 prostate lobes
    Time Frame
    day 0

    10. Eligibility

    Sex
    Male
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria 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. Exclusion criteria patient with prostate cancer or suspected of having prostate cancer 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 major surgery in the four months preceding the inclusion visit 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.)
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Jacques SEDAT
    Phone
    0492034702
    Email
    causeret.m@chu-nice.fr

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Prostatic Arterial Embolization With SQUID (Ethylene Vinyl Alcohol Copolymer )

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