About this trial
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 criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- KARL STORZ fetoscope arm