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Tiny balloon could ease prostate troubles without major surgery

NCT ID NCT07583706

Symptom relief Sponsor: Qing Yuan Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early study is testing a new, ultra-minimally invasive procedure for men with benign prostatic hyperplasia (BPH) who have significant urinary symptoms. The treatment uses a balloon catheter guided by ultrasound to gently widen the prostate passage. Only 5 men aged 40 to 80 will be enrolled to see if it safely improves urine flow and symptoms while protecting sexual function.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
prostate dilation catheter (device)
What this could lead to
If it works, this could offer a gentler option for men with BPH to relieve urinary symptoms while preserving sexual function.
What could go wrong
This is a very early, tiny study with only 5 participants. It is designed to test safety and basic effectiveness, not to prove a new standard treatment. The procedure may not work as hoped or could cause complications like bleeding or urinary problems.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 5 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2026

Expected to finish

Sep 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

40 to 80 years

Sex

Male participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Male subjects aged 40 to 80 years with symptomatic benign prostatic hyperplasia (BPH) and obvious bladder outlet obstruction. * Subjects with normal sexual life and a sexual partner, and with intact sexual function. * International Prostate Symptom Score (IPSS) ≥ 13. * Maximum urinary flow rate (Qmax) between 5 and 10 mL/s, with a minimum voided volume ≥ 150 mL. * Prostate volume measured by transrectal ultrasound (TRUS) \< 30 mL. Prostate volume is calculated as length × width × height × 0.52. * Subjects who, in the investigator's opinion, are able to complete the study protocol. Exclusion Criteria: * Subjects who are unable or unwilling to sign the informed consent form (ICF) and/or comply with all follow-up requirements. * Subjects who are unwilling to abstain from sexual activity or use protective sexual behavior within 90 days after treatment. * Prostate-specific antigen (PSA) ≥ 10 ng/mL, unless prostate cancer has been excluded by biopsy. * Confirmed or suspected prostate or bladder malignancy. * Use of antiplatelet drugs, such as clopidogrel or aspirin, within 10 days before surgery, or planned use within 5 days after surgery. * Use of medications within 3 months before surgery that, in the investigator's opinion, may affect sexual function. * Presence of neurogenic bladder or detrusor underactivity affecting bladder/sphincter function. * Patients with BPH complicated by acute urinary tract infection, acute prostatitis, or bacterial prostatitis.

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Conditions

The condition(s) this trial relates to.

benign prostatic hyperplasia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

BPH (benign prostatic hyperplasia)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Qing Yuan

    RECRUITING

    Beijing, 100000, China

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