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

Launched by THE UNIVERSITY OF TEXAS HEALTH SCIENCE CENTER, HOUSTON · May 17, 2024

Keywords

ClinConnect Summary

This clinical trial is studying two types of fetoscopes, which are special instruments used for surgeries performed while a baby is still in the womb. The main goal is to see how effective the curved version and the straight version of the Karl Storz fetoscope are for performing these in-utero surgeries. This research is important for improving surgical options for conditions that may affect the fetus or newborn.

To be eligible for this study, participants need to be pregnant women who meet certain medical criteria for in-utero surgery. They must also be able to provide signed consent, which explains the risks associated with the procedure. However, women with specific health issues, such as certain allergies, preterm labor, or major fetal anomalies, cannot participate. If someone joins the trial, they can expect to undergo a procedure using one of the fetoscopes, and their progress will be monitored closely. This research could help enhance future surgical techniques for unborn babies and their mothers.

Gender

FEMALE

Eligibility criteria

• 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

Trial Officials