STEAM-MAP 1 Study - Steam Therapy With MRI and AI-assisted Planning

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age30-80
SponsorChinese University of Hong Kong

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

  • MRI-TRUS fusion-guided Rezūm therapy

    Procedure/Surgery

    This 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

15 Participants
are divided into 1 treatment group
Group A: MRI-TRUS fusion water vapour ablationExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Feasibility: Success rate defined by completion of cases

Time frame
Peri-operative period

Secondary outcomes

1

Duration of operation

The time between scope in and scope out

Time frame
Intra-operation
2

Duration of Software fusion time

Time frame
Intra-operation
3

Number of treatment given during the operation

Time frame
Intra-operation
4

Rate of discharge on the same day of the operation

Time frame
On the day 1 of operation

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: