Fetal Cystoscopy in the Management of Lower Urinary Tract Obstruction (LUTO)
4 maggio 2026 aggiornato da: 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.
Panoramica dello studio
Stato
Iscrizione su invito
Intervento / Trattamento
Descrizione dettagliata
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 di studio
Interventistico
Iscrizione (Stimato)
10
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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Minnesota
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Rochester, Minnesota, Stati Uniti, 55905
- Mayo Clinic
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
No
Descrizione
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
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Fattibilità del dispositivo
- Assegnazione: N / A
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: 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. |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Number of procedures that achieved technical success of visualization of the bladder neck and proximal urethra
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Amniotic fluid volume after the procedure (major vertical pocket)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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.
Lasso di tempo: 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
Lasso di tempo: 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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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Investigatori
- Investigatore principale: Mauro H. Schenone, M.D., Mayo Clinic
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Stimato)
1 maggio 2026
Completamento primario (Stimato)
23 marzo 2056
Completamento dello studio (Stimato)
23 marzo 2060
Date di iscrizione allo studio
Primo inviato
16 marzo 2026
Primo inviato che soddisfa i criteri di controllo qualità
4 maggio 2026
Primo Inserito (Effettivo)
7 maggio 2026
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
7 maggio 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
4 maggio 2026
Ultimo verificato
1 aprile 2026
Maggiori informazioni
Termini relativi a questo studio
Altri numeri di identificazione dello studio
- 23-008546
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
NO
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
Sì
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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