NCT06425471NARecruiting
The Use of Karl Storz Curved Fetoscope (11508aak) and Its Straight Version (11506akk) for In-utero Surgery
The University of Texas Health Science Center, Houston
Start Date
4/4/2024
Completion Date
12/31/2028
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
Detailed 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 Criteria
Age Range: 18 years to 45 years
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
Interventions
DEVICE
KARL STORZ fetoscope arm
Conditions
In Utero Procedure Affecting Fetus or Newborn
Locations
The University of Texas health Science Center at Houston
Houston, Texas 77030
United States