Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 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.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07194187
The ClinicalTrials.gov registry entry for NCT07194187 describes a study currently listed as not yet recruiting, categorized as NA. The registered enrollment target is 17 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Icahn School of Medicine at Mount Sinai, which has 708 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which High Intensity Focused Ultrasound is the first listed.
NCT07194187 reports 0 study locations.
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
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.