In this proposal, the investigators plan to conduct a clinical trial to validate the efficacy and safety of microspheres (T-ACE Beads).
T-ACE Beads can be used for prostatic arterial embolization safely and efficiently. Furthermore, investigator's microspheres has advantageous characteristics in biodegradability, drug delivery capability, and cost-effectiveness. After the clinical trial, we anticipate introducing a new microsphere for Lower Urinary Tract Symptom/Benign prostatic hyperplasia patients, which is beneficial to the participants in precise medicine as well as in the pharmaceutical and medical device industry.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
12
Similar with conventional Transcatheter Arterial chemo-embolization, radiologist use Taiwan ACE Beads instead of Gelfoam or polyvinyl alcohol.
National Cheng Kung University Hospital
Tainan, Taiwan
RECRUITINGPatients Survival (Safety)
Survival rate was evaluated since treatment day until the date of death or final observation.
Time frame: An average of 12 weeks.
Change on Patient's Symptoms
Change on patients' International Prostate Symptom Score (IPSS)
Time frame: Before treatment, one and three months after treatment
Change on Prostate Volume
Prostate volume measured using MRI
Time frame: Before treatment, one and three months after treatment.
Change in serum Prostate Specific Antigen (PSA) concentration
Measurement of Prostate Specific Antigen in patients undergoing this treatment.
Time frame: Before treatment, one and three months after treatment.
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