Fetal Cystoscopy in the Management of Lower Urinary Tract Obstruction (LUTO)
22. juli 2026 oppdatert av: 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.
Studieoversikt
Status
Påmelding etter invitasjon
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Intervensjonell
Registrering (Antatt)
10
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Minnesota
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Rochester, Minnesota, Forente stater, 55905
- Mayo Clinic
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Beskrivelse
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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Enhetens gjennomførbarhet
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: 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. |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Number of procedures that achieved technical success of visualization of the bladder neck and proximal urethra
Tidsramme: 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
Tidsramme: 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.
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24 months
|
|
Number of procedures that achieved technical success of valvuloplasty
Tidsramme: 24 months
|
Technical success of valvuloplasty is defined as passage of balloon during dilation of valve.
|
24 months
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Amniotic fluid volume after the procedure (major vertical pocket)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
|
|
Survival rate
Tidsramme: 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
Tidsramme: 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
Tidsramme: 28 days, 3 months, 6 months, 12 months, 18 months, and 24 months of age
|
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
Tidsramme: 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
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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
Tidsramme: Baseline
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Number of neonates to show indications of severe pulmonary hypertension based on latest echocardiogram during first hospitalization.
|
Baseline
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Use of extracorporeal membrane oxygenation (ECMO) support during post-natal follow-up
Tidsramme: 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
Tidsramme: 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
Tidsramme: During first hospitalization (assessed up to 10 days)
|
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
Tidsramme: 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).
|
Baseline
|
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Total number of patients to require surgery
Tidsramme: 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.
Tidsramme: 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
Tidsramme: 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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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Mauro H. Schenone, M.D., Mayo Clinic
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
8. mai 2026
Primær fullføring (Antatt)
23. mars 2056
Studiet fullført (Antatt)
23. mars 2060
Datoer for studieregistrering
Først innsendt
16. mars 2026
Først innsendt som oppfylte QC-kriteriene
4. mai 2026
Først lagt ut (Faktiske)
7. mai 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
24. juli 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
22. juli 2026
Sist bekreftet
1. juli 2026
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- 23-008546
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