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Набор по приглашению NCT07572227

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

Без фазы С лечением Lower Urinary Tract Obstruction, Congenital

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Fetal cystoscope.
Кому может быть актуально
Состояния в реестре: Lower Urinary Tract Obstruction, Congenital. Базовые параметры: от 18 лет · Женщины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

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.

Подробное описание

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.

Вмешательства

  • Устройство 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.

Первичные конечные точки

  • Number of procedures that achieved technical success of visualization of the bladder neck and proximal urethra [Срок оценки: 24 months]
  • Number of procedures that achieved technical success of posterior urethral valve ablation with laser to allow passage of balloon [Срок оценки: 24 months]
  • Number of procedures that achieved technical success of valvuloplasty [Срок оценки: 24 months]
Вторичные конечные точки (12)
  • Amniotic fluid volume after the procedure (major vertical pocket) [Срок оценки: 24 hours after procedure]
  • Fetal lung growth after treatment [Срок оценки: Baseline]
  • Number of fetuses to experience complications [Срок оценки: Baseline]
  • Number of mothers to experience complications [Срок оценки: Baseline]
  • Gestational age at delivery [Срок оценки: Gestational age at delivery, up to 9 months]
  • Renal changes after treatment [Срок оценки: 24 months]
  • Survival rate [Срок оценки: 28 days, 3 months, 6 months, 12 months, 18 months, and 24 months of age]
  • Serum creatinine level [Срок оценки: 28 days, 3 months, 6 months, 12 months, 18 months, and 24 months of age]
  • Need for dialysis [Срок оценки: 28 days, 3 months, 6 months, 12 months, 18 months, and 24 months of age]
  • Grading of oxygen dependency [Срок оценки: 28 days, 3 months, 6 months, 12 months, 18 months, and 24 months of age]
  • Occurrence of severe pulmonary hypertension [Срок оценки: Baseline]
  • Use of extracorporeal membrane oxygenation (ECMO) support during post-natal follow-up [Срок оценки: 24 months]

Критерии участия

Критерии включения

  • 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

Критерии исключения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Оценка устройства

Центры проведения

США · 1 центр
  • Mayo Clinic — Rochester

Идентификаторы

NCT: NCT07572227 · 23-008546

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗