Laparotomy Versus Percutaneous Endoscopic Correction of Myelomeningocele

Recruiting N/A Interventional Study
Neural Tube Defects Spina Bifida Myelomeningocele Chiari Malformation
No Placebo Group Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
18 and older
Sex
Female
Study type
Interventional
Purpose
Treatment
Participants needed
12 (estimated)
Sponsor
USFetus · Other
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About This Trial

The purpose of this study is to evaluate the feasibility of a fetoscopic surgical technique for antenatal correction of fetal myelomeningocele. Two surgical approaches will be utilized. The percutaneous approach will be offered to participants with a posterior placenta. The laparotomy/uterine exteriorization approach will be offered to participants regardless of placental location.

Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. Myelomeningocele (including myeloschisis) at level T1 through S1 with hindbrain herniation. Lesion level and hindbrain herniation will be confirmed by MRI and ultrasonography. 2. Maternal age ≥18 years. 3. Gestational age of 19 to 27 6/7 weeks' gestation as determined by clin…
Contacts

Ruben Quintero, MD

720-753-3825

q@the-fetal-institute.com

CONTACT

Ramen Chmait, MD

626-356-3360

chmait@usc.edu

CONTACT