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New treatment option for Benign Prostatic Hyperplasia
Official title The Edison System for Treatment of Benign Prostatic Hyperplasia (BPH) Using Histotripsy
ClinicalTrials.gov ID: NCT07214675
What this study is testing
- What it's testing
- The purpose of this trial is to evaluate the safety of histotripsy using the HistoSonics Edison System for treatment of BPH.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 50 and older, men only
You may be able to join if
- Subject is ≥ 50 years of age.
- Subject has signed the Ethics Committee (EC) approved trial Informed Consent Form (ICF) prior to any trial related tests/procedures and is willing to...
- Subject is diagnosed with BPH.
- Subject has a Body Mass Index (BMI) \< 27.
- Subject has an I-PSS ≥ 15.
You likely can't join if
- Subject has a life expectancy of less than one (1) year.
- Subject has a known sensitivity to contrast media and cannot be adequately pre-medicated.
- Subject has a post-void residual ≥ 150 mL confirmed via ultrasound.
- Subject has an estimated glomerular filtration rate (eGFR) ≤ 50 mL/min, ≤ 14 days prior to the planned index procedure date.
- Subject has uncorrectable coagulopathy.
- Subject has an International Normalized Ratio (INR) value ˃ 2.0, ≤14 days prior to the planned index procedure date.
See the full eligibility criteria
- Subject is ≥ 50 years of age.
- Subject has signed the Ethics Committee (EC) approved trial Informed Consent Form (ICF) prior to any trial related tests/procedures and is willing to comply with trial procedures and required follow-up assessments.
- Subject is diagnosed with BPH.
- Subject has a Body Mass Index (BMI) \< 27.
- Subject has an I-PSS ≥ 15.
- Subject has a prostate volume \> 30 mL and ≤ 150 mL.
- Subject has a Qmax ≤ 15 mL/s with a voided volume of ≥ 125 mL during a uroflow test.
- Subject accepts the potential loss of ejaculatory function.
- Subject can tolerate general anesthesia. Index-Procedure Imaging Inclusion (Assessed day of procedure)
- Subject has an adequate acoustic window to visualize the prostate using the HistoSonics Edison System.
- Target treatment volume is ≥ 1 cm from the rectum as visualized on ultrasound, CT or MR imaging.
- Subject has a life expectancy of less than one (1) year.
- Subject has a known sensitivity to contrast media and cannot be adequately pre-medicated.
- Subject has a post-void residual ≥ 150 mL confirmed via ultrasound.
- Subject has an estimated glomerular filtration rate (eGFR) ≤ 50 mL/min, ≤ 14 days prior to the planned index procedure date.
- Subject has uncorrectable coagulopathy.
- Subject has an International Normalized Ratio (INR) value ˃ 2.0, ≤14 days prior to the planned index procedure date.
- Subject has had a prostatectomy.
- Subject has acute prostatitis.
- Subject has a diagnosis of or has received treatment for chronic prostatitis or chronic pelvic pain syndrome.
- Subject has had a urinary tract infection (UTI) ≤ 3 months prior to the planned index procedure date.
- Subject has bladder stones.
- Subject is catheter dependent or has a history of intermittent self-catheterization.
- Presence of prostatic calcifications in the planned treatment volume (PTV).
- Presence of permanent radioactive implants in the rectal wall.
- Subject has has a major abdominal or rectal surgery that inhibits visualization of the prostate.
- Subject has undergone prior locoregional therapy (e.g., Rezum, laser, Urolift, TURP emboli, or radiation).
- Subject has planned locoregional therapy 6 months post index procedure (e.g., Rezum, laser, Urolift, TURP emboli, or radiation).
- people who have active cancers (not in remission for the last two years) other than non-melanomatous skin cancers.
- Subject is being actively treated in another pharmaceutical or device trial that has not completed its primary endpoint prior to the index procedure or may interfere with the primary outcome measure of this trial.
- In the investigator's opinion, histotripsy is not a treatment option for the subject.
- Subject has a concurrent condition that could jeopardize the safety of the subject or compliance with the protocol.
- Subject's prostate is not treatable by the System's working ranges (refer to User Guide).
The study team makes the final eligibility decision.
Where it's taking place
- Shatin, Hong Kong
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 50 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shatin, Hong Kong. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.