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.
調査の概要
詳細な説明
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.
研究の種類
介入
入学 (推定)
10
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
-
-
Minnesota
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Rochester、Minnesota、アメリカ、55905
- Mayo Clinic
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-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：デバイスの実現可能性
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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. |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Number of procedures that achieved technical success of visualization of the bladder neck and proximal urethra
時間枠：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
時間枠：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
時間枠：24 months
|
Technical success of valvuloplasty is defined as passage of balloon during dilation of valve.
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24 months
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Amniotic fluid volume after the procedure (major vertical pocket)
時間枠：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
時間枠：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
|
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Number of fetuses to experience complications
時間枠：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
時間枠：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
時間枠：Gestational age at delivery, up to 9 months
|
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
時間枠：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
時間枠：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
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28 days, 3 months, 6 months, 12 months, 18 months, and 24 months of age
|
|
Serum creatinine level
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：During first hospitalization (assessed up to 10 days)
|
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)
|
|
Ventilator support during the first hospitalization
時間枠：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
時間枠：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
|
|
Total number of patients to require surgery
時間枠：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.
時間枠：Two weeks from day of admission
|
Total number of days in hospital after giving birth
|
Two weeks from day of admission
|
|
Operative times
時間枠：During procedure
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Length of time to complete fetal cystoscopy, reported in minutes
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During procedure
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
捜査官
- 主任研究者：Mauro H. Schenone, M.D.、Mayo Clinic
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2026年5月8日
一次修了 (推定)
2056年3月23日
研究の完了 (推定)
2060年3月23日
試験登録日
最初に提出
2026年3月16日
QC基準を満たした最初の提出物
2026年5月4日
最初の投稿 (実際)
2026年5月7日
学習記録の更新
投稿された最後の更新 (実際)
2026年7月24日
QC基準を満たした最後の更新が送信されました
2026年7月22日
最終確認日
2026年7月1日
詳しくは
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