Fetal Cystoscopy in the Management of Lower Urinary Tract Obstruction (LUTO)
2026年7月22日 更新者：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.
研究概览
详细说明
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.
研究类型
介入性
注册 (估计的)
10
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
Minnesota
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Rochester、Minnesota、美国、55905
- Mayo Clinic
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-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：设备可行性
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：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. |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Number of procedures that achieved technical success of visualization of the bladder neck and proximal urethra
大体时间：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
大体时间：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
大体时间：24 months
|
Technical success of valvuloplasty is defined as passage of balloon during dilation of valve.
|
24 months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Amniotic fluid volume after the procedure (major vertical pocket)
大体时间：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
大体时间：Baseline
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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
大体时间：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
|
|
Number of mothers to experience complications
大体时间：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
|
|
Gestational age at delivery
大体时间：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
大体时间：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
大体时间：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
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|
Serum creatinine level
大体时间：28 days, 3 months, 6 months, 12 months, 18 months, and 24 months of age
|
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
|
|
Need for dialysis
大体时间：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
大体时间：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
大体时间：Baseline
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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
大体时间：24 months
|
Number of neonates to require ECMO support at any point during the first 24 months
|
24 months
|
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Days in neonatal intensive care unit during the first hospitalization
大体时间：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
大体时间：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
大体时间：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
大体时间：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.
大体时间：Two weeks from day of admission
|
Total number of days in hospital after giving birth
|
Two weeks from day of admission
|
|
Operative times
大体时间：During procedure
|
Length of time to complete fetal cystoscopy, reported in minutes
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During procedure
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
赞助
调查人员
- 首席研究员：Mauro H. Schenone, M.D.、Mayo Clinic
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2026年5月8日
初级完成 (估计的)
2056年3月23日
研究完成 (估计的)
2060年3月23日
研究注册日期
首次提交
2026年3月16日
首先提交符合 QC 标准的
2026年5月4日
首次发布 (实际的)
2026年5月7日
研究记录更新
最后更新发布 (实际的)
2026年7月24日
上次提交的符合 QC 标准的更新
2026年7月22日
最后验证
2026年7月1日
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