Fetal Cystoscopy in the Management of Lower Urinary Tract Obstruction (LUTO)
22 de julho de 2026 atualizado por: Mauro H. Schenone, Mayo Clinic
The purpose of this research is to determine the feasibility and safety of performing fetal operative cystoscopy for the treatment of Lower Urinary Tract Obstruction (LUTO) using investigational devices.
Visão geral do estudo
Status
Inscrevendo-se por convite
Intervenção / Tratamento
Descrição detalhada
Fetal cystoscopy involves the use of a tiny camera to find the cause of the urinary tract blockage and to treat it at the same time. When a fetus is found to have LUTO, this means there is a blockage in the urethra (tube that passes urine from the bladder to outside the body) which leads to kidney, lung, and other organ damage in the fetus.
Fetal surgery is when the unborn baby is in the mother's uterus (in utero). This study will see if certain investigational devices are safe for the fetal cystoscopy procedure.
Tipo de estudo
Intervencional
Inscrição (Estimado)
10
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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Minnesota
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Rochester, Minnesota, Estados Unidos, 55905
- Mayo Clinic
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Não
Descrição
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
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Viabilidade do dispositivo
- Alocação: N / D
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: Fetal operative cystoscopy
Patients pregnant with a male baby who has a lower urinary tract obstruction
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The fetoscope assembly includes the the Boston Scientific Maverick 2 balloon catheter and Emerge balloon, the Karl Storz Miniature Straight Forward Telescope, Operating Sheath, and connector. A fetal cystoscopy will be performed for treatment of lower urinary tract obstruction complicated by oligo/anhydramnios. |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Number of procedures that achieved technical success of visualization of the bladder neck and proximal urethra
Prazo: 24 months
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Technical success of visualization is defined as the ability to visualize the bladder neck and proximal urethra during the procedures.
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24 months
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Number of procedures that achieved technical success of posterior urethral valve ablation with laser to allow passage of balloon
Prazo: 24 months
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Technical success of posterior urethral valve ablation with laser to allow passage of balloon is defined as completing urethral valve ablation during the procedure.
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24 months
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Number of procedures that achieved technical success of valvuloplasty
Prazo: 24 months
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Technical success of valvuloplasty is defined as passage of balloon during dilation of valve.
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24 months
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Amniotic fluid volume after the procedure (major vertical pocket)
Prazo: 24 hours after procedure
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Amniotic fluid volume is reported based on ultrasound measurements of Maximum Vertical Pocket (MVP), and is reported in centimeters (cm)
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24 hours after procedure
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Fetal lung growth after treatment
Prazo: Baseline
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Fetal lung growth will be determined by observed Lung area to Head circumference Ratio (LHR) = Lung area / Head circumference
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Baseline
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Number of fetuses to experience complications
Prazo: Baseline
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Fetal safety will be assessed as number of fetuses to experience complications, defined as premature delivery, prelabor rupture of membranes, injury to the fetus, abdominal hernia, vesicoamniotic or vesicoperitoneal fistula, chorioamniotic separation, fetal bleeding, bradycardia, fetal anemia, brain injury, or death
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Baseline
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Number of mothers to experience complications
Prazo: Baseline
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Maternal safety will be assessed as number of mothers to experience complications, defined as wound infection, chorioamnionitis, bleeding, injury to surrounding organs, amniotic fluid leak, prelabor rupture of membranes, placental abruption, preterm delivery, pseudomembranous colitis, mirror syndrome/preeclampsia, or death.
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Baseline
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Gestational age at delivery
Prazo: Gestational age at delivery, up to 9 months
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Gestational age at time of delivery, reported in weeks
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Gestational age at delivery, up to 9 months
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Renal changes after treatment
Prazo: 24 months
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Number of patients to experience renal pelvis anteroposterior diameter, presence or absence of renal cystic changes, improvement or worsening of hydronephrosis
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24 months
|
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Survival rate
Prazo: 28 days, 3 months, 6 months, 12 months, 18 months, and 24 months of age
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Survival of neonates at post natal follow up points of 28 days, 3 months, 6 months, 12 months, 18 months, and 24 months of age
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28 days, 3 months, 6 months, 12 months, 18 months, and 24 months of age
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Serum creatinine level
Prazo: 28 days, 3 months, 6 months, 12 months, 18 months, and 24 months of age
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Serum creatinine level will be measured by blood test
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28 days, 3 months, 6 months, 12 months, 18 months, and 24 months of age
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Need for dialysis
Prazo: 28 days, 3 months, 6 months, 12 months, 18 months, and 24 months of age
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Number of neonates to require dialysis
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28 days, 3 months, 6 months, 12 months, 18 months, and 24 months of age
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Grading of oxygen dependency
Prazo: 28 days, 3 months, 6 months, 12 months, 18 months, and 24 months of age
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Grading of oxygen dependency is categorized as: none, mild, moderate, or severe
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28 days, 3 months, 6 months, 12 months, 18 months, and 24 months of age
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Occurrence of severe pulmonary hypertension
Prazo: Baseline
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Number of neonates to show indications of severe pulmonary hypertension based on latest echocardiogram during first hospitalization.
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Baseline
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Use of extracorporeal membrane oxygenation (ECMO) support during post-natal follow-up
Prazo: 24 months
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Number of neonates to require ECMO support at any point during the first 24 months
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24 months
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Days in neonatal intensive care unit during the first hospitalization
Prazo: During first hospitalization (assessed up to 10 days)
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Total number of days in neonatal intensive care unit during the first hospitalization
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During first hospitalization (assessed up to 10 days)
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Ventilator support during the first hospitalization
Prazo: During first hospitalization (assessed up to 10 days)
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Total number of days of ventilator support during the first hospitalization
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During first hospitalization (assessed up to 10 days)
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Presence of neonatal sepsis
Prazo: Baseline
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Total number of neonates to experience neonatal sepsis, defined as intraventricular hemorrhage (grade 3 or higher), retinopathy of prematurity (grade 3 or higher).
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Baseline
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Total number of patients to require surgery
Prazo: Baseline
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Total number of patients to require surgery to treat posterior urethral valves or to deal with complications of in utero procedure
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Baseline
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Days of maternal hospitalization.
Prazo: Two weeks from day of admission
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Total number of days in hospital after giving birth
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Two weeks from day of admission
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Operative times
Prazo: During procedure
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Length of time to complete fetal cystoscopy, reported in minutes
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During procedure
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Investigador principal: Mauro H. Schenone, M.D., Mayo Clinic
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
8 de maio de 2026
Conclusão Primária (Estimado)
23 de março de 2056
Conclusão do estudo (Estimado)
23 de março de 2060
Datas de inscrição no estudo
Enviado pela primeira vez
16 de março de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
4 de maio de 2026
Primeira postagem (Real)
7 de maio de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
24 de julho de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
22 de julho de 2026
Última verificação
1 de julho de 2026
Mais Informações
Termos relacionados a este estudo
Outros números de identificação do estudo
- 23-008546
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
NÃO
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Sim
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