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Trial NCT06056635

A Prospective Study on the Role of Karl Storz Curved and Straight Fetoscopes (11508AAK and 11506AAK) for Fetoscopic Intrauterine Procedures

Phase
Not given
Sponsor
Boston Children's Hospital
Conditions
Fetal Conditions; Maternal; Procedure; Pregnancy Related; Twin to Twin Transfusion Syndrome; In Utero Procedure Affecting Fetus or Newborn; Chorion; Abnormal; Twin Reversal Arterial Perfusion Syndrome; Twin Monochorionic Monoamniotic Placenta; Chorioangioma; Vasa Previa
Ages
18–45 years
View on ClinicalTrials.gov ↗

Eligibility criteria

Highlighted: restrictions our model extracted, each a verbatim quote (pink = excludes outright, blue = only under conditions).

Inclusion Criteria: * Pregnant patient with a condition requiring in-utero surgery * Patient must be eligible for anesthesia * Patient and father of the fetus (if available) are able to provide signed informed consent Exclusion Criteria: * Allergy or previous adverse reaction to any ancillary medication specified in this protocol that has no alternative * Preterm labor, preeclampsia, or uterine anomaly (e.g., large fibroid tumor) in the index pregnancy * Suspicion of major recognized congenital syndrome on ultrasound or MRI that is not compatible with postnatal life * Pre-pregnancy maternal BMI greater than 40BMI * High risk for fetal hemophilia * Fetal aneuploidy or variants of known significance if an amniocentesis was performed * Contraindication to abdominal surgery or fetoscopic surgery

Restrictions found (1)

Recruiting in Massachusetts

  • Boston Children's Hospital · Boston, Suffolk County