Status:
RECRUITING
A Prospective Study on the Role of Karl Storz Curved and Straight Fetoscopes (11508AAK and 11506AAK) for Fetoscopic Intrauterine Procedures
Lead Sponsor:
Boston Children's Hospital
Conditions:
Fetal Conditions
Maternal; Procedure
Eligibility:
FEMALE
18-45 years
Phase:
NA
Brief Summary
In this research study, the investigators want to learn more about the role of new innovative surgical devices, the Karl Storz Curved and Straight Fetoscopes for in-utero surgery. A fetoscope is like ...
Detailed Description
The objective of this study is to evaluate the benefit of Karl Storz curved (11508AAK) and straight (11506AAK) fetoscopes for in-utero surgery. The investigators will assess the surgical outcomes, sho...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 15 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2027
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT06056635
Start Date
August 15 2024
End Date
May 1 2027
Last Update
September 25 2024
Active Locations (1)
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1
Boston Children's Hospital
Boston, Massachusetts, United States, 02115