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NCT07194187 · ClinicalTrials.gov registry record · NA
High Intensity Focused Ultrasound (HIFU) Ablation for Treatment of Prostate Tissue in Bladder Outlet Obstruction
A NA study, sponsored by Icahn School of Medicine at Mount Sinai.
- Not yet
- Registry status
- NA
- Development phase
- 17
- Enrollment target
NCT07194187: Clinical Trial NA study, sponsored by Icahn School of Medicine at Mount Sinai.
NCT07194187 is a NA study that has not yet begun recruiting, run by Icahn School of Medicine at Mount Sinai. The registered enrollment target is 17 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07194187, a NA study, has not yet begun recruiting, sponsored by Icahn School of Medicine at Mount Sinai.
- NOT YET RECRUITING
- Registry status
- NA
- Development phase
- 17 participants
- Enrollment target
Study Summary
Objectives: To assess the efficacy of HIFU therapy for benign prostatic tissue ablation in patients with lower urinary tract symptoms (LUTS) due to bladder outlet obstruction (BOO) that caused by Benign prostatic hyperplasia (BPH). The primary objective of the study is to determine the efficacy of HIFU therapy by assessing the changes in IPSS score in 6-month post HIFU procedure for BPH with compared to baseline. The secondary objectives of this study are as follow: * To assess any adverse events related to the procedure or device. * To assess the operation related characteristics including: total operation time and ablation time required in HIFU procedure for BPH, total catheterization time after the HIFU procedure for BPH, and categorical ablation zone * To assess the patient's post operative pain level at different post op time points. * To assess the urinary flow and symptoms improvement by studying the changes in IPSS, Qmax, and PVR at different post op time points compared to the baseline. * To assess the effectiveness of HIFU by studying the changes in PSA levels, types of medication for BPH or any urologic condition, proportion of patients who are taking BPH medication, prostate volume, and prostate calcification level and the reoperation rate within 12-month post-op. * To assess changes in patients' sexual function at different post op time points. The hypothesis is that a HIFU ablation is a safe and effective treatment for patients with LUTS due to BOO from BPH.
Primary Outcome
The International Prostate Symptom Score (I-PSS) is designed to assess severity of symptoms in benign prostatic hypertrophy. It is based on the answers to seven questions concerning urinary symptoms and one question concerning quality of life. Each question concerning urinary symptoms allows the patient to choose one out of six answers indicating increasing severity of the particular symptom. The answers are assigned points from 0 to 5. The total score can therefore range from 0 to 35 with highe
Interventions
- DEVICE High Intensity Focused Ultrasound
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 17 participants |
| Start Date | 2026-06-01 |
| Est. Completion | 2027-09-20 |
| Phase | NA |
What is known before NCT07194187 opens enrollment
NCT07194187 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 17 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 1 intervention - of which High Intensity Focused Ultrasound is the first listed.
NCT07194187 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07194187 about?
NCT07194187 is a clinical study titled "High Intensity Focused Ultrasound (HIFU) Ablation for Treatment of Prostate Tissue in Bladder Outlet Obstruction". Objectives: To assess the efficacy of HIFU therapy for benign prostatic tissue ablation in patients with lower urinary tract symptoms (LUTS) due to bladder outlet obstruction (BOO) that caused by Benign prostatic hyperplasia (BPH). The primary objective of the study is to determine the efficacy of ...
What is the current status of trial NCT07194187?
This trial is currently not yet recruiting. It is a NA study. The enrollment target is 17 participants. The study started on 2026-06-01. Estimated completion is 2027-09-20.
What interventions are being tested in trial NCT07194187?
The interventions under investigation include: High Intensity Focused Ultrasound (DEVICE).
Who is sponsoring clinical trial NCT07194187?
This trial is sponsored by Icahn School of Medicine at Mount Sinai, which has 708 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07194187's enrollment target sits among peer trials
17 1871st of 2000 higher than 130 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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