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临床试验/NCT06425471
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

The University of Texas Health Science Center, Houston2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2024年4月4日最近更新:
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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jimmy Espinoza

Professor

The University of Texas Health Science Center, Houston

研究点 (2)

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