Fetal Cystoscopy in the Management of Lower Urinary Tract Obstruction (LUTO)
22 juillet 2026 mis à jour par: 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.
Aperçu de l'étude
Statut
Inscription sur invitation
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Interventionnel
Inscription (Estimé)
10
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
-
-
Minnesota
-
Rochester, Minnesota, États-Unis, 55905
- Mayo Clinic
-
-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Non
La description
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 d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Faisabilité de l'appareil
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Fetal operative cystoscopy
Patients pregnant with a male baby who has a lower urinary tract obstruction
|
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. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Number of procedures that achieved technical success of visualization of the bladder neck and proximal urethra
Délai: 24 months
|
Technical success of visualization is defined as the ability to visualize the bladder neck and proximal urethra during the procedures.
|
24 months
|
|
Number of procedures that achieved technical success of posterior urethral valve ablation with laser to allow passage of balloon
Délai: 24 months
|
Technical success of posterior urethral valve ablation with laser to allow passage of balloon is defined as completing urethral valve ablation during the procedure.
|
24 months
|
|
Number of procedures that achieved technical success of valvuloplasty
Délai: 24 months
|
Technical success of valvuloplasty is defined as passage of balloon during dilation of valve.
|
24 months
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Amniotic fluid volume after the procedure (major vertical pocket)
Délai: 24 hours after procedure
|
Amniotic fluid volume is reported based on ultrasound measurements of Maximum Vertical Pocket (MVP), and is reported in centimeters (cm)
|
24 hours after procedure
|
|
Fetal lung growth after treatment
Délai: Baseline
|
Fetal lung growth will be determined by observed Lung area to Head circumference Ratio (LHR) = Lung area / Head circumference
|
Baseline
|
|
Number of fetuses to experience complications
Délai: Baseline
|
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
|
|
Number of mothers to experience complications
Délai: Baseline
|
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
|
|
Gestational age at delivery
Délai: Gestational age at delivery, up to 9 months
|
Gestational age at time of delivery, reported in weeks
|
Gestational age at delivery, up to 9 months
|
|
Renal changes after treatment
Délai: 24 months
|
Number of patients to experience renal pelvis anteroposterior diameter, presence or absence of renal cystic changes, improvement or worsening of hydronephrosis
|
24 months
|
|
Survival rate
Délai: 28 days, 3 months, 6 months, 12 months, 18 months, and 24 months of age
|
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
|
28 days, 3 months, 6 months, 12 months, 18 months, and 24 months of age
|
|
Serum creatinine level
Délai: 28 days, 3 months, 6 months, 12 months, 18 months, and 24 months of age
|
Serum creatinine level will be measured by blood test
|
28 days, 3 months, 6 months, 12 months, 18 months, and 24 months of age
|
|
Need for dialysis
Délai: 28 days, 3 months, 6 months, 12 months, 18 months, and 24 months of age
|
Number of neonates to require dialysis
|
28 days, 3 months, 6 months, 12 months, 18 months, and 24 months of age
|
|
Grading of oxygen dependency
Délai: 28 days, 3 months, 6 months, 12 months, 18 months, and 24 months of age
|
Grading of oxygen dependency is categorized as: none, mild, moderate, or severe
|
28 days, 3 months, 6 months, 12 months, 18 months, and 24 months of age
|
|
Occurrence of severe pulmonary hypertension
Délai: Baseline
|
Number of neonates to show indications of severe pulmonary hypertension based on latest echocardiogram during first hospitalization.
|
Baseline
|
|
Use of extracorporeal membrane oxygenation (ECMO) support during post-natal follow-up
Délai: 24 months
|
Number of neonates to require ECMO support at any point during the first 24 months
|
24 months
|
|
Days in neonatal intensive care unit during the first hospitalization
Délai: During first hospitalization (assessed up to 10 days)
|
Total number of days in neonatal intensive care unit during the first hospitalization
|
During first hospitalization (assessed up to 10 days)
|
|
Ventilator support during the first hospitalization
Délai: During first hospitalization (assessed up to 10 days)
|
Total number of days of ventilator support during the first hospitalization
|
During first hospitalization (assessed up to 10 days)
|
|
Presence of neonatal sepsis
Délai: Baseline
|
Total number of neonates to experience neonatal sepsis, defined as intraventricular hemorrhage (grade 3 or higher), retinopathy of prematurity (grade 3 or higher).
|
Baseline
|
|
Total number of patients to require surgery
Délai: Baseline
|
Total number of patients to require surgery to treat posterior urethral valves or to deal with complications of in utero procedure
|
Baseline
|
|
Days of maternal hospitalization.
Délai: Two weeks from day of admission
|
Total number of days in hospital after giving birth
|
Two weeks from day of admission
|
|
Operative times
Délai: During procedure
|
Length of time to complete fetal cystoscopy, reported in minutes
|
During procedure
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chercheur principal: Mauro H. Schenone, M.D., Mayo Clinic
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
8 mai 2026
Achèvement primaire (Estimé)
23 mars 2056
Achèvement de l'étude (Estimé)
23 mars 2060
Dates d'inscription aux études
Première soumission
16 mars 2026
Première soumission répondant aux critères de contrôle qualité
4 mai 2026
Première publication (Réel)
7 mai 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
24 juillet 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
22 juillet 2026
Dernière vérification
1 juillet 2026
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- 23-008546
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
NON
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Oui
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .