The Use of Karl Storz Curved Fetoscope (11508aak) and Its Straight Version (11506akk) for In-utero Surgery

The University of Texas System (UT)

Status

Enrolling

Conditions

In Utero Procedure Affecting Fetus or Newborn

Treatments

Device: KARL STORZ fetoscope arm

Study type

Interventional

Funder types

Other

Identifiers

NCT06425471

HSC-MS-22-1019

Details and patient eligibility

About

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

Full description

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

Enrollment

50 estimated patients

Sex

Female

Ages

18 to 45 years old

Volunteers

No Healthy Volunteers

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