NCT06425471招募中不适用
A Prospective Study on the Efficacy of the Karl Storz Curved Fetoscope (11508aak) and Its Straight Version (11506akk) for In-utero Surgery
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Gestational age at delivery in patients requiring percutaneous in-utero surgery
研究概览
简要总结
The purpose of this study is to prospectively evaluate the efficacy of KARL STORZ curved fetoscope (11508AAK) and its straight version (11506AAK) for in-utero surgery
详细描述
Outcome data will be compared to that of The Fetal Center's historical control group that underwent in-utero surgery without curved fetoscopes
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pregnant woman
- •The patient fulfills the criteria for in-utero surgery based on the standard of care, which is specific for each condition
- •Patient of the baby provides signed informed consent that details the maternal and fetal risks involved with the procedure
排除标准
- •Contraindication to abdominal surgery, fetoscopic surgery, or general anesthesia
- •Allergy or previous adverse reaction to a study medication specified in this protocol
- •Preterm labor, preeclampsia, or a uterine anomaly (e.g., large fibroid tumor) that is unavoidable during surgery in the index pregnancy
- •Fetal aneuploidy, genomic variants of known significance if an amniocentesis has been performed, other major fetal anomalies or disorders that may impact the fetal/neonatal survival, or a known syndromic mutation
- •Suspicion of a major recognized syndrome by ultrasound or MRI
- •Maternal BMI >40 kg/m2
- •High risk for fetal hemophilia
结局指标
主要结局
Gestational age at delivery in patients requiring percutaneous in-utero surgery
时间窗: at time of delivery (about 10 weeks after in utero surgery)
次要结局
- Number of successful procedures with completion of laser ablation of the abnormal vessels.(within 24 hours of in utero surgery)
- Improved visualization as assessed by the Likert scale(within 24 hours of in utero surgery)
- Improved ease of use of the new fetoscope as assessed by a questionnaire(within 24 hours of in utero surgery)
- Operative time in minutes(end of surgery ( about 1 hour form start of surgery))
- Number of fetuses alive prior to hospital discharge(time of discharge (about 48 hours after surgery))
- The number of participants that develop twin-anemia-polycythemia sequence (TAPS)(from end of surgery to within 10 weeks after surgery)
- Total number of live births(from time of in utero surgery till delivery (about 10 weeks after surgery))
- Improved angle for laser visualization as assessed by the Likert scale(within 24 hours of in utero surgery)
- Total number of patients that have maternal and/or fetal perioperative complications(from end of surgery to within 10 weeks after surgery)
- Total number of maternal patients that present with short term morbidity(from end of surgery to within 10 weeks after surgery)
- Total number of short-term morbidities(from time of in utero surgery till delivery (about 10 weeks after surgery))
研究者
Jimmy Espinoza
Professor
The University of Texas Health Science Center, Houston
研究点 (2)
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