Status:
NOT_YET_RECRUITING
Fetoscopic Robotic Open Spina Bifida Treatment
Lead Sponsor:
Mount Sinai Hospital, Canada
Collaborating Sponsors:
The Hospital for Sick Children
Conditions:
Fetal Congenital Abnormalities
Fetoscopy
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
Fetal spina bifida is a common birth defect that results in hydrocephalus, motor-, bowel-, bladder- and sexual dysfunction in the child. The condition is progressive in utero. Fetal surgery between 22...
Eligibility Criteria
Inclusion
- Isolated open fetal spina bifida
- Healthy pregnant patient without risk factors for preterm delivery
- Candidate for open fetal spina bifida surgery.
- Maternal age 18 years or more and able to consent
- Provision of written informed consent to participate in this study
- Gestational age allowing for fetal surgery prior to 26 weeks gestation.
Exclusion
- Contraindication for surgery or safe anesthesia due to a severe maternal medical condition, including morbid obesity (BMI \>40 kg/m2)
- History of preterm birth, short cervical length, cervical cerclage
- Placenta or vasa previa, invasive placentation
- Inaccessibility of the uterus due to severe maternal obesity, uterine fibroids, bowel or placental superposition
- Major fetal structural or genetic anomalies unrelated to spina bifida, requiring surgery or potentially leading to infant death or severe handicap
- Neural tube defects other than open spina bifida
- Absence of Chiari II malformation on ultrasound or MRI
- Severe fetal kyphosis (\>30 degrees)
- Upper lesion level lower than sacral vertebra S1.
- Multiple gestation
- Fetal bleeding disorder (eg. Fetal/neonatal allo-immune thrombocytopenia)
- Maternal infectious disorder which could result in materno-fetal transmission (eg HIV with high viral load)
Key Trial Info
Start Date :
July 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2027
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT06907732
Start Date
July 1 2025
End Date
December 1 2027
Last Update
May 7 2025
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