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Fetal Cystoscopy in the Management of Lower Urinary Tract Obstruction (LUTO)

4. maj 2026 opdateret af: 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.

Studieoversigt

Status

Tilmelding efter invitation

Betingelser

Intervention / Behandling

Detaljeret 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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

10

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Minnesota
      • Rochester, Minnesota, Forenede Stater, 55905
        • Mayo Clinic

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Enhedens gennemførlighed
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Fetal operative cystoscopy
Patients pregnant with a male baby who has a lower urinary tract obstruction
Enhed: Fetal cystoscope

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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number of procedures that achieved technical success of visualization of the bladder neck and proximal urethra
Tidsramme: 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
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.
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
Foranstaltningsbeskrivelse
Tidsramme
Amniotic fluid volume after the procedure (major vertical pocket)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
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
28 days, 3 months, 6 months, 12 months, 18 months, and 24 months of age
Occurrence of severe pulmonary hypertension
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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.
Tidsramme: Two weeks from day of admission
Total number of days in hospital after giving birth
Two weeks from day of admission
Operative times
Tidsramme: During procedure
Length of time to complete fetal cystoscopy, reported in minutes
During procedure

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Mayo Clinic

Efterforskere

  • Ledende efterforsker: Mauro H. Schenone, M.D., Mayo Clinic

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. maj 2026

Primær færdiggørelse (Anslået)

23. marts 2056

Studieafslutning (Anslået)

23. marts 2060

Datoer for studieregistrering

Først indsendt

16. marts 2026

Først indsendt, der opfyldte QC-kriterier

4. maj 2026

Først opslået (Faktiske)

7. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

7. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

4. maj 2026

Sidst verificeret

1. april 2026

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • 23-008546

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ja

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