LC Bead LUMI for Prostatic Artery Embolization

NCT03372096 | Completed Results FDA Device

• 1 other identifier: 17-2782
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 2

Brief Summary

Purpose: The purpose of this pilot study is to determine preliminary estimates of the parameters related to the distribution of the study endpoints including: International Prostate Symptom Score (IPSS) and quality of life (QoL) score changes, Qmax (maximum urine flow rate) changes, post void residual volume (PVR) changes, percent prostate infarction and presence of non-target embolization. Participants: 20 adult male subjects with benign hyperplasia will be enrolled in this study. Procedures (methods): This will be a multisite, open label pilot study with a small population undergoing an investigational intervention (prostatic artery embolization) to determine initial safety and potential for efficacy as measured by improvement of lower urinary tract symptoms (LUTS) and decrease in prostate size.

Conditions

BPH

Keywords

embolization; prostate

Outcome Measures

Primary Outcomes (1)

• Mean Change in IPSS Score

  The International Prostate Symptom Score (IPSS) is an 8 item Likert questionnaire (7 symptom questions + 1 quality of life question) with scores ranging from 0 to 5, where 0 is less severe. IPSS is a written screening tool used to screen for, rapidly diagnose, track the symptoms of, and suggest management of the symptoms of the disease benign prostatic hyperplasia (BPH). Total scores are determined to be Mild (1-7), Moderate (8-19), or Severe (20-35).

  Baseline and 6 months following PAE procedure

Secondary Outcomes (7)

• Mean Change in Quality of Life Scores

  Baseline and 6 months following PAE procedure

• Mean Change in Urine Flow

  Baseline and 6 months following PAE Procedure

• Mean Change in Prostate Volume

  Baseline and 3 months following

• Percent of Prostate Infarcted

  6 months following PAE procedure

• Number of Participants That Have Non-Targeted Embolization Following the Prostatic Artery Embolization (PAE) Procedure

  3 months following PAE procedure

Study Arms (1)

All patients

EXPERIMENTAL

Patients will receive the Prostatic Artery Embolization procedure.

Device: Prostatic Artery Embolization

Interventions

Prostatic Artery Embolization DEVICE

LC Bead LUMI is a spherical polyvinyl alcohol embolic particle that incorporates radiopaque moieties. Once a catheter has been fluoroscopically guided into the target vessel, the beads are then injected, causing obstruction at the arteriole level until the desired degree of embolization has occurred.

Also known as: LC Bead LUMI

All patients

Eligibility Criteria

• Age: 40 Years+
• Gender Eligibility Details: Gender is based on the anatomical gender assigned at birth. Patients must have a prostate in order to enroll in this study.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male
• Age \> 40
• Prostate gland \>50 grams as measured by pre-procedural CT angiogram (CTA)
• Have previously taken BPH medication for 6 months without desired improvement of LUTS or has started medication and stopped due to unwanted side effects
• Moderate to severe LUTS as defined by IPSS score \>18
• Peak urine flow rate (Qmax) \<12 mL/sec
• Capable of giving informed consent
• Life expectancy greater than 1 year

You may not qualify if:

• Severe vascular disease
• Uncontrolled diabetes mellitus
• Immunosuppression
• Neurogenic bladder and/or sphincter abnormalities secondary to Parkinson's disease, multiple sclerosis, cerebral vascular accident, diabetes, etc.
• Complete urinary retention
• Impaired kidney function (serum creatinine level \> 1.8 mg/dL or a glomerular filtration rate \< 60 as approximated using serum creatinine levels) unless anuric and on dialysis.
• Confirmed or suspected bladder cancer
• Urethral strictures, bladder neck contracture, or other potentially confounding bladder pathology
• Ongoing urogenital infection
• Previous pelvic radiation or radical pelvic surgery
• Confirmed or suspected malignancy of the prostate based on digital rectal exam (DRE), transrectal ultrasonography (TRUS) or prostate-specific antigen (PSA) (\> 10 ng/mL or \> 4.0 ng/mL and \< 10 ng/mL with free PSA \< 25% of total PSA without a negative biopsy).
• Uncorrectable coagulopathy including international normalized ratio (INR) \> 1.5 or platelets \< 50,000
• Contrast hypersensitivity refractory to standard medications (antihistamines, steroids)

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• BTG International Inc.: collaborator

Study Sites (2)

UNC Hospitals

Chapel Hill, North Carolina, 27599, United States

Location

Vascular Institute of Virginia

Woodbridge, Virginia, 22193, United States

Location

Results Point of Contact

• Title: Associate Director of Clinical Research Operations, Department of Radiology
• Organization: University of North Carolina at Chapel Hill

rad_research@med.unc.edu

919-966-4997

Study Officials

• Ari Isaacson, MD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

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

Model Details: This will be an open label pilot study with a small population undergoing an intervention to determine initial safety and potential for efficacy as measured by improvement of LUTS and decrease in prostate size

Study Record Dates

• First Submitted: December 8, 2017
• First Posted: December 13, 2017
• Study Start: July 13, 2018
• Primary Completion: September 3, 2020
• Study Completion: September 3, 2020
• Last Updated: February 24, 2021
• Results First Posted: February 5, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)