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Could a blood clot improve penile surgery in boys?

NCT ID NCT07319780

Disease control Sponsor: National Children's Medical Center, Uzbekistan 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study compares two surgical techniques for correcting a common birth defect in boys where the urine opening is on the underside of the penis. One method uses a graft from tissue, while the other uses a special membrane made from the patient's own blood (platelet-rich fibrin) to help healing. The goal is to see which approach leads to fewer complications like fistulas or narrowing of the opening. The trial will involve 100 boys aged 6 months to 7 years.

What this could mean

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

Active substance
autologous platelet-rich fibrin membrane
What this could lead to
If it works, this could offer a safer, more effective surgical technique for boys with hypospadias, reducing the need for follow-up procedures.
What could go wrong
This is a relatively small, early-stage trial (100 participants) comparing two surgical methods. The benefit of platelet-rich fibrin is not yet proven, and surgical outcomes can vary widely.

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 100 people

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

Started

Jan 2026

Expected to finish

Dec 2028

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

6 to 84 months

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 children aged 6 months to 84 months * Primary or redo distal hypospadias * Unfavorable urethral plate * Penile curvature less than 45 degrees after degloving * Eligibility for tubularized incised plate urethroplasty Exclusion Criteria: * Disorders of sex development or ambiguous genitalia * Severe penile curvature requiring urethral plate transection * Previous graft-based urethroplasty * Active local or systemic infection at the time of surgery * Known bleeding or platelet disorders * Inability to comply with postoperative follow-up

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Conditions

The condition(s) this trial relates to.

hypospadias

As listed by the trial registrant

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

Distal hypospadias Hypospadias

How to take part

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

  1. The places running it

    2 sites in 2 countries. 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

  • Dr. Cipto Mangunkusumo Hospital

    NOT_YET_RECRUITING

    Jakarta, DKI Jakarta, 10430, Indonesia

  • National Children's Medical Center

    RECRUITING

    Tashkent, Tashkent, 100020, Uzbekistan

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