Fetal Cystoscopy in the Management of Lower Urinary Tract Obstruction (LUTO)
22 de julio de 2026 actualizado 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.
Descripción general del estudio
Estado
Inscripción por invitación
Intervención / Tratamiento
Descripción detallada
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 estudio
Intervencionista
Inscripción (Estimado)
10
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Minnesota
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Rochester, Minnesota, Estados Unidos, 55905
- Mayo Clinic
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
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
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Viabilidad del dispositivo
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
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. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Number of procedures that achieved technical success of visualization of the bladder neck and proximal urethra
Periodo de tiempo: 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
Periodo de tiempo: 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
|
|
Number of procedures that achieved technical success of valvuloplasty
Periodo de tiempo: 24 months
|
Technical success of valvuloplasty is defined as passage of balloon during dilation of valve.
|
24 months
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Amniotic fluid volume after the procedure (major vertical pocket)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
|
Baseline
|
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Number of mothers to experience complications
Periodo de tiempo: 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.
|
Baseline
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Gestational age at delivery
Periodo de tiempo: 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
|
|
Renal changes after treatment
Periodo de tiempo: 24 months
|
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
|
|
Survival rate
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
|
|
Grading of oxygen dependency
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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.
Periodo de tiempo: 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
Periodo de tiempo: 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
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Mauro H. Schenone, M.D., Mayo Clinic
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
8 de mayo de 2026
Finalización primaria (Estimado)
23 de marzo de 2056
Finalización del estudio (Estimado)
23 de marzo de 2060
Fechas de registro del estudio
Enviado por primera vez
16 de marzo de 2026
Primero enviado que cumplió con los criterios de control de calidad
4 de mayo de 2026
Publicado por primera vez (Actual)
7 de mayo de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
24 de julio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
22 de julio de 2026
Última verificación
1 de julio de 2026
Más información
Términos relacionados con este estudio
Otros números de identificación del estudio
- 23-008546
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Sí
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .