The Use of Karl Storz Curved Fetoscope (11508aak) and Its Straight Version (11506akk) for In-utero Surgery

Официальное название

A Prospective Study on the Efficacy of the Karl Storz Curved Fetoscope (11508aak) and Its Straight Version (11506akk) for In-utero Surgery

Обзор

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

Подробное описание

Outcome data will be compared to that of The Fetal Center's historical control group that underwent in-utero surgery without curved fetoscopes

Вмешательства

• Устройство KARL STORZ fetoscope arm
  The type of fetoscope used in utero(either straight or curved or both ) will depend on the location of the placenta. The fetoscope will be used to cauterize abnormal blood vessels that cause twin-to-twin transfusion syndrome (TTTS)

Первичные конечные точки

• Gestational age at delivery in patients requiring percutaneous in-utero surgery [Срок оценки: at time of delivery (about 10 weeks after in utero surgery)]

Вторичные конечные точки (11)

• Number of successful procedures with completion of laser ablation of the abnormal vessels. [Срок оценки: within 24 hours of in utero surgery]
• Improved visualization as assessed by the Likert scale [Срок оценки: within 24 hours of in utero surgery]
• Improved angle for laser visualization as assessed by the Likert scale [Срок оценки: within 24 hours of in utero surgery]
• Improved ease of use of the new fetoscope as assessed by a questionnaire [Срок оценки: within 24 hours of in utero surgery]
• Operative time in minutes [Срок оценки: end of surgery ( about 1 hour form start of surgery)]
• Number of fetuses alive prior to hospital discharge [Срок оценки: time of discharge (about 48 hours after surgery)]
• Total number of maternal patients that present with short term morbidity [Срок оценки: from end of surgery to within 10 weeks after surgery]
• Total number of patients that have maternal and/or fetal perioperative complications [Срок оценки: from end of surgery to within 10 weeks after surgery]
• The number of participants that develop twin-anemia-polycythemia sequence (TAPS) [Срок оценки: from end of surgery to within 10 weeks after surgery]
• Total number of live births [Срок оценки: from time of in utero surgery till delivery (about 10 weeks after surgery)]
• Total number of short-term morbidities [Срок оценки: from time of in utero surgery till delivery (about 10 weeks after surgery)]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• The University of Texas health Science Center at Houston — Houston

Идентификаторы

NCT: NCT06425471 · HSC-MS-22-1019

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗