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A Prospective Study on the Efficacy of the 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

Recruiting
18-45 years
Female
Phase N/A

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Overview

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

Description

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

Eligibility

Inclusion Criteria:

  • 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 Criteria:

  • 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

Study details
    In Utero Procedure Affecting Fetus or Newborn

NCT06425471

The University of Texas Health Science Center, Houston

28 May 2024

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