A Prospective Study on the Role of Karl Storz Curved and Straight Fetoscopes (11508AAK and 11506AAK) for Fetoscopic Intrauterine Procedures

Launched by BOSTON CHILDREN'S HOSPITAL · Sep 21, 2023

Keywords

ClinConnect Summary

This clinical trial is studying the use of two new surgical tools called the Karl Storz Curved and Straight Fetoscopes. These tools are designed to help doctors see inside the uterus during minimally invasive surgery, which is a way to treat certain fetal conditions without needing large incisions. The curved fetoscope is used for patients with a placenta at the front of the uterus, while the straight one is for those with a placenta at the back. The study aims to understand how effective these devices are in performing procedures that help manage conditions like Twin to Twin Transfusion Syndrome and other complications that can arise during pregnancy.

To participate in this study, pregnant women must have a condition that requires in-utero surgery and be eligible for anesthesia. They should also be able to give consent along with the father of the fetus, if available. Participants can expect to be closely monitored during the procedure, and the researchers will collect information on the outcomes of the surgeries, any complications, and the health of the babies. It's important to note that certain health conditions, such as severe obesity or major congenital syndromes, may exclude someone from joining the trial.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • Pregnant patient with a condition requiring in-utero surgery
• • Patient must be eligible for anesthesia
• • Patient and father of the fetus (if available) are able to provide signed informed consent
• Exclusion Criteria:
• • Allergy or previous adverse reaction to any ancillary medication specified in this protocol that has no alternative
• • Preterm labor, preeclampsia, or uterine anomaly (e.g., large fibroid tumor) in the index pregnancy
• • Suspicion of major recognized congenital syndrome on ultrasound or MRI that is not compatible with postnatal life
• • Pre-pregnancy maternal BMI greater than 40
• • High risk for fetal hemophilia
• • Fetal aneuploidy or variants of known significance if an amniocentesis was performed
• • Contraindication to abdominal surgery or fetoscopic surgery