Fetal Cystoscopy in the Management of Lower Urinary Tract Obstruction (LUTO)
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- Mayo Clinic
- 入组人数
- 10
- 试验地点
- 1
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Fetal operative cystoscopy
Patients pregnant with a male baby who has a lower urinary tract obstruction
干预措施: Fetal cystoscope (Device)
研究者
Mauro H. Schenone
Principal Investigator
Mayo Clinic