Fetal surgery breakthrough: tiny camera could save Babies' bladders
NCT ID NCT07572227
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.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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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
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About 10 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2026
- Expected to finish
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Mar 2060
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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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
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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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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A doctor treating you
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Contacts and locations
Locations
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Mayo Clinic
Rochester, Minnesota, 55905, United States
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