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
About this trial
This is an interventional treatment trial for Prostatic Hyperplasia, Benign
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.)
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
NCT ID
NCT05395299
First Posted
April 29, 2022
Last Updated
May 24, 2022
Sponsor
Centre Hospitalier Universitaire de Nice
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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