Fetal Cystoscopy in the Management of Lower Urinary Tract Obstruction (LUTO)
2026년 7월 22일 업데이트: 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.
연구 개요
상세 설명
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.
연구 유형
중재적
등록 (추정된)
10
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Minnesota
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Rochester, Minnesota, 미국, 55905
- Mayo Clinic
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 장치 타당성
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Fetal operative cystoscopy
Patients pregnant with a male baby who has a lower urinary tract obstruction
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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. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Number of procedures that achieved technical success of visualization of the bladder neck and proximal urethra
기간: 24 months
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Technical success of visualization is defined as the ability to visualize the bladder neck and proximal urethra during the procedures.
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24 months
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Number of procedures that achieved technical success of posterior urethral valve ablation with laser to allow passage of balloon
기간: 24 months
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Technical success of posterior urethral valve ablation with laser to allow passage of balloon is defined as completing urethral valve ablation during the procedure.
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24 months
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Number of procedures that achieved technical success of valvuloplasty
기간: 24 months
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Technical success of valvuloplasty is defined as passage of balloon during dilation of valve.
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24 months
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Amniotic fluid volume after the procedure (major vertical pocket)
기간: 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
기간: Baseline
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Fetal lung growth will be determined by observed Lung area to Head circumference Ratio (LHR) = Lung area / Head circumference
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Baseline
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Number of fetuses to experience complications
기간: 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
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Baseline
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Number of mothers to experience complications
기간: 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.
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Baseline
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Gestational age at delivery
기간: Gestational age at delivery, up to 9 months
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Gestational age at time of delivery, reported in weeks
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Gestational age at delivery, up to 9 months
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Renal changes after treatment
기간: 24 months
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Number of patients to experience renal pelvis anteroposterior diameter, presence or absence of renal cystic changes, improvement or worsening of hydronephrosis
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24 months
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Survival rate
기간: 28 days, 3 months, 6 months, 12 months, 18 months, and 24 months of age
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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
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Serum creatinine level
기간: 28 days, 3 months, 6 months, 12 months, 18 months, and 24 months of age
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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
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Need for dialysis
기간: 28 days, 3 months, 6 months, 12 months, 18 months, and 24 months of age
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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
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Grading of oxygen dependency
기간: 28 days, 3 months, 6 months, 12 months, 18 months, and 24 months of age
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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
기간: Baseline
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Number of neonates to show indications of severe pulmonary hypertension based on latest echocardiogram during first hospitalization.
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Baseline
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Use of extracorporeal membrane oxygenation (ECMO) support during post-natal follow-up
기간: 24 months
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Number of neonates to require ECMO support at any point during the first 24 months
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24 months
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Days in neonatal intensive care unit during the first hospitalization
기간: During first hospitalization (assessed up to 10 days)
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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)
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Ventilator support during the first hospitalization
기간: During first hospitalization (assessed up to 10 days)
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Total number of days of ventilator support during the first hospitalization
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During first hospitalization (assessed up to 10 days)
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Presence of neonatal sepsis
기간: 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).
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Baseline
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Total number of patients to require surgery
기간: Baseline
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Total number of patients to require surgery to treat posterior urethral valves or to deal with complications of in utero procedure
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Baseline
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Days of maternal hospitalization.
기간: Two weeks from day of admission
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Total number of days in hospital after giving birth
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Two weeks from day of admission
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Operative times
기간: During procedure
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Length of time to complete fetal cystoscopy, reported in minutes
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During procedure
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
스폰서
수사관
- 수석 연구원: Mauro H. Schenone, M.D., Mayo Clinic
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2026년 5월 8일
기본 완료 (추정된)
2056년 3월 23일
연구 완료 (추정된)
2060년 3월 23일
연구 등록 날짜
최초 제출
2026년 3월 16일
QC 기준을 충족하는 최초 제출
2026년 5월 4일
처음 게시됨 (실제)
2026년 5월 7일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 7월 24일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 7월 22일
마지막으로 확인됨
2026년 7월 1일
추가 정보
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기타 연구 ID 번호
- 23-008546
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아니요
약물 및 장치 정보, 연구 문서
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아니
미국 FDA 규제 기기 제품 연구
예
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