The Use of Karl Storz Curved Fetoscope (11508aak) and Its Straight Version (11506akk) for In-utero Surgery
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, Houston
50 participants
Apr 4, 2024
INTERVENTIONAL
Conditions
Summary
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
Eligibility
Inclusion Criteria3
- 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
Exclusion Criteria7
- 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
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Interventions
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)
Locations(1)
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NCT06425471