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

4. Mai 2026 aktualisiert von: 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.

Studienübersicht

Status

Anmeldung auf Einladung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Geschätzt)

10

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Vereinigte Staaten
    • Minnesota
      • Rochester, Minnesota, Vereinigte Staaten, 55905
        • Mayo Clinic

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Machbarkeit des Geräts
  • Zuteilung: N / A
  • Interventionsmodell: Einzelgruppenzuweisung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Fetal operative cystoscopy
Patients pregnant with a male baby who has a lower urinary tract obstruction
Gerät: 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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Number of procedures that achieved technical success of visualization of the bladder neck and proximal urethra
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 24 months
Technical success of valvuloplasty is defined as passage of balloon during dilation of valve.
24 months

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Amniotic fluid volume after the procedure (major vertical pocket)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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.
Zeitfenster: Two weeks from day of admission
Total number of days in hospital after giving birth
Two weeks from day of admission
Operative times
Zeitfenster: During procedure
Length of time to complete fetal cystoscopy, reported in minutes
During procedure

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Mayo Clinic

Ermittler

  • Hauptermittler: Mauro H. Schenone, M.D., Mayo Clinic

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

1. Mai 2026

Primärer Abschluss (Geschätzt)

23. März 2056

Studienabschluss (Geschätzt)

23. März 2060

Studienanmeldedaten

Zuerst eingereicht

16. März 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

4. Mai 2026

Zuerst gepostet (Tatsächlich)

7. Mai 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

7. Mai 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

4. Mai 2026

Zuletzt verifiziert

1. April 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Andere Studien-ID-Nummern

  • 23-008546

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Ja

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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