Taiwan ACE Beads for Embolization Therapy in Symptomatic Benign Prostatic Hyperplasia
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03239652|
Recruitment Status : Recruiting
First Posted : August 4, 2017
Last Update Posted : April 4, 2018
|Condition or disease||Intervention/treatment||Phase|
|Lower Urinary Tract Symptom Benign Prostatic Hyperplasia (BPH)||Device: Taiwan ACE Beads||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Safety and Efficacy of Prostatic Artery Embolization Therapy in Symptomatic Benign Prostatic Hyperplasia|
|Actual Study Start Date :||January 1, 2017|
|Estimated Primary Completion Date :||September 30, 2018|
|Estimated Study Completion Date :||December 31, 2018|
Experimental: Taiwan ACE Beads microspheres
The maximum use of dosage will not exceed 100 milligrams. The embolization procedure usually lasts less than an hour.
Device: Taiwan ACE Beads
Similar with conventional Transcatheter Arterial chemo-embolization, radiologist use Taiwan ACE Beads instead of Gelfoam or polyvinyl alcohol.
- Patients Survival (Safety) [ Time Frame: An average of 12 weeks. ]Survival rate was evaluated since treatment day until the date of death or final observation.
- Change on Patient's Symptoms [ Time Frame: Before treatment, one and three months after treatment ]Change on patients' International Prostate Symptom Score (IPSS)
- Change on Prostate Volume [ Time Frame: Before treatment, one and three months after treatment. ]Prostate volume measured using MRI
- Change in serum Prostate Specific Antigen (PSA) concentration [ Time Frame: Before treatment, one and three months after treatment. ]Measurement of Prostate Specific Antigen in patients undergoing this treatment.
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): NCT03239652
|Contact: Xi-Zhang Lin, MD||886-6-2353535 ext email@example.com|
|Contact: Hui-Yu Hung, Bachelor||886-6-2353535 ext firstname.lastname@example.org|
|National Cheng Kung University Hospital||Recruiting|
|Contact: Xi-Zhang Lin, MD 886-6-2353535 ext 3624 email@example.com|
|Contact: Hui-Yu Hung, Bachelor 886-6-2353535 ext 3624 firstname.lastname@example.org|
|Principal Investigator: Yuh-Shyan Tsai, MD|
|Principal Investigator:||Yuh-Shyan Tsai, MD||Department of Urology, National Cheng Kung University Hospital, College of medicine, National Cheng Kung University, Tainan 70403, Taiwan|