The Efficacy of the KARL STORZ Curved Fetoscope and Straight Fetoscope for Laser Photocoagulation of Placental Anastomoses

Официальное название

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

Обзор

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).

Вмешательства

• Устройство Curved KARL STORZ fetoscope
  The KARLZ STORZ curved scope is used to see the inside of a pregnant person's uterus during minimally invasive surgery, similar to conventional scopes. The curved scope is rounded and thought to help visualize the anterior placenta because of its position on the uterus.
• Устройство Conventional Scopes
  The conventional scopes are regularly used during laser photocoagulation of placental anastomoses.

Первичные конечные точки

• Operative time in minutes [Срок оценки: during surgery]

Вторичные конечные точки (12)

• Number of Participants that have a gestational age of less than 37 weeks [Срок оценки: 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 [Срок оценки: end of surgery (about 60 minutes after start of surgery)]
• Total number of procedures with completion of the laser ablation [Срок оценки: end of surgery (about 60 minutes after start of surgery)]
• Improved visualization as assessed by the Likert scale [Срок оценки: end of surgery (about 60 minutes after start of surgery)]
• Improved angle for laser visualization as assessed by the Likert scale [Срок оценки: end of surgery (about 60 minutes after start of surgery)]
• Total number of fetuses alive, after the laser photocoagulation procedure [Срок оценки: at discharge from hospital (about 24 hours after surgery)]
• Total number of maternal patients that present with morbidity [Срок оценки: at discharge from hospital (about 24 hours after surgery)]
• Total number of patients that have maternal and/or fetal perioperative complications [Срок оценки: end of surgery (about 60 minutes after start of surgery)]
• The number of participants that develop twin-anemia-polycythemia sequence (TAPS) [Срок оценки: end of surgery (about 60 minutes after start of surgery)]
• Number of live births [Срок оценки: at time of delivery (about 20 weeks from surgery)]
• Number of neonates with a short-term morbidity [Срок оценки: from birth until hospital discharge]
• Infant development score using the Ages & Stages Questionnaires, Third Edition (ASQ-3) [Срок оценки: 24 months of age]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

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

Идентификаторы

NCT: NCT06084247 · HSC-MS-23-0622

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗