Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06601179
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-08
Brief Title:
Evaluating the Safety and Efficacy of the HIFU High-intensity Focused Ultrasound Treatment of Benign Prostatic Hyperplasia
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Phase 1-2 Dose-escalation Study Evaluating the Safety and Efficacy of the HIFU High-intensity Focused Ultrasound Treatment of Benign Prostatic Hyperplasia After 3 Months 6 Months 12 Months 18 Months and 36 Months
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BPH EFFICACY
Brief Summary:
Prostate adenoma also known as benign prostatic hypertrophy or hyperplasia BPH involves an increase in the size of the prostate forming a benign tumor It is the most common benign tumor in men generally affecting those over 40 years old The risk of BPH is more than 50 in men aged 50 to 60 and rises to 90 in men by age 80
This hyperplasia leads to altered urinary flow and bladder outlet obstruction referred to as lower urinary tract symptoms or LUTS which become more frequent with age These symptoms are categorized as obstructive or irritative In the early stages men with BPH may have difficulty starting urination and may feel as if their bladder is not completely empty As a result they need to urinate more often especially at night a condition known as nocturia Additionally the volume and velocity of the urinary flow may decrease significantly as evidenced by flow measurements and residual urine discharge may occur at the end of urination
High-intensity focused ultrasound HIFU is a medical technique that uses high-intensity ultrasonic waves to treat various medical conditions including malignant and benign tumors without the need for invasive surgery or ionizing radiation HIFU generates heat between 80 to 95C at the focal point causing necrosis of the targeted area with pinpoint accuracy In urology HIFU is used to treat prostate cancer in a minimally invasive manner with focused ultrasounds delivered endorectally using a transducer that targets the treatment area with real-time monitoring
Exclusively targeted HIFU treatment has been suggested for BPH where localized necrosis of the side lobes reduces the volume of the prostatic transition zone alleviating compression of the prostatic urethra and improving urinary symptoms
This new study was initiated to evaluate the safety and efficacy of HIFU for BPH treatment
This hyperplasia leads to altered urinary flow and bladder outlet obstruction referred to as lower urinary tract symptoms or LUTS which become more frequent with age These symptoms are categorized as obstructive or irritative In the early stages men with BPH may have difficulty starting urination and may feel as if their bladder is not completely empty As a result they need to urinate more often especially at night a condition known as nocturia Additionally the volume and velocity of the urinary flow may decrease significantly as evidenced by flow measurements and residual urine discharge may occur at the end of urination
High-intensity focused ultrasound HIFU is a medical technique that uses high-intensity ultrasonic waves to treat various medical conditions including malignant and benign tumors without the need for invasive surgery or ionizing radiation HIFU generates heat between 80 to 95C at the focal point causing necrosis of the targeted area with pinpoint accuracy In urology HIFU is used to treat prostate cancer in a minimally invasive manner with focused ultrasounds delivered endorectally using a transducer that targets the treatment area with real-time monitoring
Exclusively targeted HIFU treatment has been suggested for BPH where localized necrosis of the side lobes reduces the volume of the prostatic transition zone alleviating compression of the prostatic urethra and improving urinary symptoms
This new study was initiated to evaluate the safety and efficacy of HIFU for BPH treatment
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None