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Fetal surgery breakthrough: tiny camera could save Babies' bladders

NCT ID NCT07572227

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 24, 2026 · Updated 1 time

Summary

This study tests a new fetal surgery for unborn boys with a blocked urinary tract (LUTO). The procedure uses a tiny camera to see inside the bladder and clear the blockage, aiming to improve fluid levels and lung growth. About 10 pregnant women will be enrolled to see if the approach is safe and works.

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 10 people

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

Started

May 2026

Expected to finish

Mar 2060

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

18 years and older

Sex

Female 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: * 18 years of age or older * Pregnant women carrying a singleton gestation and male fetus * Able to perform the procedure at a gestational age between 16 0/7 and 25 6/7 weeks of gestation * Lower urinary tract obstruction: Enlarged bladder (subjectively assessed), keyhole sign, bladder wall thickening (subjectively assessed), and bilateral hydro (uretero) nephrosis.27 * Absence of chromosomal abnormalities and other anomalies unrelated to the urinary tract obstruction. * Oligo or anhydramnios at or after 16 weeks of gestation * Evidence of conserved renal function (a Nassr et al., score of 3 or less ). * Able to understand the requirements of the study, and willing and able to consent for enrollment in the study Exclusion Criteria: * Severe maternal health condition precluding procedure. * Increased risk for preterm labor including short cervical length, history of incompetent cervix with or without cerclage, and previous preterm birth * Placental abnormalities (previa, abruption, accreta) known at time of enrollment * Contraindications to surgery including previous hysterotomy in active uterine segment (at or above the level of the round ligaments). * Maternal-fetal Rh isoimmunization, Kell sensitization or neonatal alloimmune thrombocytopenia affecting the current pregnancy * Maternal HIV, Hepatitis-B, Hepatitis-C status positive because of the increased risk of transmission to the fetus during maternal-fetal surgery o * Female fetus * Significant pathogenic or likely pathogenic finding on karyotype or microarray * Significant unrelated fetal anomaly, as opposed to a nonsignificant one that would not preclude enrollment. * Multiple gestation * Technical limitations precluding the procedure, such as, no fetoscopic approach due to placental position or fetal position. * Inability to comply with travel and follow-up requirements of the trial

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

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  1. The places running it

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

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

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  3. A doctor treating you

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Contacts and locations

Locations

  • Mayo Clinic

    Rochester, Minnesota, 55905, United States

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Other studies related to the condition(s) this trial covers.