About this trial
The STEAM-MAP 1 Study is a single-arm, prospective feasibility trial evaluating the integration of MRI-transrectal ultrasound (TRUS) fusion guidance into Rezūm water vapor thermal therapy for men with symptomatic benign prostatic hyperplasia (BPH).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 30-80 years old with symptomatic BPH.
Prostate volume 30-80 mL (TRUS/MRI/US)
Suitable for Rezum.
Able to consent and comply with follow-up to 1 month.
Disqualifiers
Known/suspected prostate cancer requiring oncologic management.
Prior prostate surgery impacting urethral anatomy within 12 months.
Prior implant affecting urethral anatomy.
Active UTI or untreated bacteriuria pre-op.
Trial design
Single group
Treatments tested in this trial
MRI-TRUS fusion-guided Rezūm therapy
Procedure/SurgeryThis study involves MRI-TRUS fusion-guided planning and delivery of Rezūm water vapor thermal therapy for men with symptomatic benign prostatic hyperplasia (BPH). All participants will receive the investigational workflow during their Rezūm procedure. This is a single-arm study with no concurrent control group.
Treatment groups
Trial outcomes
Primary outcomes
Feasibility: Success rate defined by completion of cases
Secondary outcomes
Duration of operation
The time between scope in and scope out
Duration of Software fusion time
Number of treatment given during the operation
Rate of discharge on the same day of the operation
Sponsors and contacts
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This trial is not recruiting at the moment. You can still explore other options: