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Use of a Novel Radiopaque Embolic Agent in Prostatic Artery Embolisation for Symptomatic Benign Prostatic Enlargement

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ClinicalTrials.gov Identifier: NCT03109925
Recruitment Status : Not yet recruiting
First Posted : April 12, 2017
Last Update Posted : April 12, 2017
Sponsor:
Collaborator:
BTG International Inc.
Information provided by (Responsible Party):
University Hospital Southampton NHS Foundation Trust

Brief Summary:
This is a study protocol for the use of a novel radiopaque embolic agent in the treatment of lower urinary tract Symptoms (LUTS) with prostatic artery embolisation (PAE). This study will allow us to evaluate the safety and efficacy of this embolic in PAE along with giving us a better understanding of embolic distribution.

Condition or disease Intervention/treatment Phase
Benign Prostatic Hyperplasia Device: DC Lumi Bead, BTG Phase 2

Detailed Description:

This is a study protocol for the use of a novel radiopaque embolic agent in the treatment of lower urinary tract Symptoms (LUTS) with prostatic artery embolisation (PAE). This study will allow us to evaluate the safety and efficacy of this embolic in PAE along with giving us a better understanding of embolic distribution. It would also give us answers to:

  • How does embolic efficacy compare to current available embolic agents?
  • Does enhancement on rotational CT correlate with embolic distribution?
  • How does embolic distribution compare with tissue infarction?
  • Does the density of embolic packing correlate with degree of infarction and volume loss?
  • How predictable is superselective target embolisation?
  • Does embolic distribution vary with anatomy and gland size?
  • Does embolic distribution tally with glandular enhancement/ transitional zone vascularity?
  • If visible, what is the effect and significance of non target embolisation? This is a cohort study aiming to recruit 22 patients to power a non-inferiority assessment comparing the novel embolic agent against current available embolics.

Data will be added to our on going local registry of patients who have undergone this procedure . This will provide information about how safe and effective it is for patients and how it compares to the other established embolic agents such as polyvinyl alcohol (PVA) and other spherical agents such as Embospheres and Embozenes.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 22 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Single group of patients undergoing prostate artery embolization with a new embolic which is radio-opaque and can give a better idea of embolization distribution (DC Lumi Beads by BTG)
Masking: None (Open Label)
Masking Description: No masking
Primary Purpose: Treatment
Official Title: Use of a Novel Radiopaque Embolic Agent in Prostatic Artery Embolisation for Symptomatic Benign Prostatic Enlargement
Estimated Study Start Date : May 2017
Estimated Primary Completion Date : May 2018
Estimated Study Completion Date : May 2018

Arm Intervention/treatment
Experimental: Radio-opaque embolic arm
Patients will undergo intervention in the form of prostate artery embolization with the new radio-opaque embolic "Lumi-Bead" developed by BTG plc.
Device: DC Lumi Bead, BTG
Embolic agent which is radio-opaque




Primary Outcome Measures :
  1. Adverse event rate [ Time Frame: 12 months ]
    Rate of adverse events compared with currently available other embolic agents


Secondary Outcome Measures :
  1. Scale of symptomatic improvement [ Time Frame: 12 months ]
    symptomatic improvement will be gauged used the internationally recognised IPSS questionnaire. Decrease in IPSS score in study participants will be compared against other embolic agents in the literature



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Ages Eligible for Study:   50 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 50-80 Moderate to severe lower urinary tract symptoms secondary to benign prostatic enlargement (BPE) IPSS>14, QOL≥4 Prostate volume ≥ 40 cc Maximum urinary flow rate < 12ml/s Medically refractory BPE > 6 months (or unable/ unwilling to tolerate medical treatment due to side effects)

Exclusion Criteria:

  • Atherosclerosis of the prostatic arteries Surgical indications (Chronic retention, bladder diverticulae, urethral stenosis), detrusor instability, neurogenic bladder Malignancy (TRUS/ MRI/ Biopsy proven). PSA > 4 or high SWOP risk need prostate biopsy Urodynamics - non-obstructed eGFR ≤ 45ml min-1m-2

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03109925


Contacts
Contact: Drew Maclean drew.maclean@uhs.nhs.uk

Sponsors and Collaborators
University Hospital Southampton NHS Foundation Trust
BTG International Inc.
Investigators
Principal Investigator: Timothy Bryant University of Hospital Southampton

Responsible Party: University Hospital Southampton NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT03109925     History of Changes
Other Study ID Numbers: BTG03752
First Posted: April 12, 2017    Key Record Dates
Last Update Posted: April 12, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Currently there is no plan to make individual participant data available to other researchers.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by University Hospital Southampton NHS Foundation Trust:
PAE
embolization
non-surgical
prostate artery embolization
radio-opaque embolic

Additional relevant MeSH terms:
Hyperplasia
Prostatic Hyperplasia
Hypertrophy
Pathologic Processes
Prostatic Diseases
Genital Diseases, Male
Pathological Conditions, Anatomical