NCT06084247尚未招募不适用
An Open Label Randomized-control Study on the Efficacy of the KARL STORZ Curved Fetoscope (11508aak) and Its Straight Version (11506aak) for Laser Photocoagulation of Placental Anastomoses
Jimmy Espinoza2 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2025年9月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 160
- 试验地点
- 2
- 主要终点
- Operative time in minutes
研究概览
简要总结
The purpose of this study is to evaluate the efficacy of KARL STORZ curved fetoscope (11508AAK) and its straight version (11506AAK) for laser photocoagulation of placental anastomoses in patients with an anterior placenta and Twin to Twin Transfusion Syndrome (TTTS).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •pregnancy
- •The patient fulfills the criteria for laser photocoagulation of placental anastomoses based on the standard of care
- •fetal diagnosis of twin-to-twin transfusion syndrome
- •Anterior placenta
- •The patient 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
- •The patient does not fulfill the conventional criteria to undergo in-utero surgery, which is specific for each surgery
- •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
Operative time in minutes
时间窗: during surgery
Time from from operative cannula insertion until it is removed
次要结局
- Total number of fetuses alive, after the laser photocoagulation procedure(at discharge from hospital (about 24 hours after surgery))
- Number of live births(at time of delivery (about 20 weeks from surgery))
- Infant development score using the Ages & Stages Questionnaires, Third Edition (ASQ-3)(24 months of age)
- Number of Participants that have a gestational age of less than 37 weeks(at time of delivery (about 20 weeks from surgery))
- Number of times additional fetoscopes are entered into the amniotic cavity to confirm completion of the in-utero intervention(end of surgery (about 60 minutes after start of surgery))
- Total number of procedures with completion of the laser ablation(end of surgery (about 60 minutes after start of surgery))
- Improved visualization as assessed by the Likert scale(end of surgery (about 60 minutes after start of surgery))
- Improved angle for laser visualization as assessed by the Likert scale(end of surgery (about 60 minutes after start of surgery))
- Total number of maternal patients that present with morbidity(at discharge from hospital (about 24 hours after surgery))
- Total number of patients that have maternal and/or fetal perioperative complications(end of surgery (about 60 minutes after start of surgery))
- The number of participants that develop twin-anemia-polycythemia sequence (TAPS)(end of surgery (about 60 minutes after start of surgery))
- Number of neonates with a short-term morbidity(from birth until hospital discharge)
研究者
Jimmy Espinoza
Professor
The University of Texas Health Science Center, Houston
研究点 (2)
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