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Fetoscopic Robotic Open Spina Bifida Treatment

NCT06907732 · Mount Sinai Hospital, Canada · Updated 7 May 2025

What is being tested
Fetoscopic robotic open spina bifida closure
For
Fetal Congenital Abnormalities; Fetoscopy; Fetal Surgery; Robotic Surgical Procedure; Neural Tube Defect; Open Spina Bifida
Kind of study
Tests a treatment or device on volunteers. No drug phase (a device or procedure study).
Who can join
Ages 18 years and older. About 15 people. The full rules are on the registry page.
Where
Not stated
When
Starts or started July 2025, ends Dec 2027. Registered 2 April 2025.
Results
None posted yet.

In the researchers' words

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 22-26 weeks gestation has been shown to stop the gradual fetal deterioration observed in this disease and improve infant outcomes. Children with spina bifida who have undergone fetal surgery have a lower need for hydrocephalus treatment (80%-\>40%) and twice the chance to walk independently by the age of 3 years (20%-\>40%). These benefits are also sustained in the longer term. The traditional 'open' fetal surgical approach, however, as currently offered clinically at the Ontario Fetal Centre, comes with significant risks: it increases the risk of preterm birth, carries significant maternal morbidity and results in important uterine scarring. The latter comes with a risk of uterine rupture and fetal death both in the index pregnancy and future pregnancies. To overcome these down sides of open fetal surgery, different centers have attempted a fetoscopic approach to the surgery. Fetoscopy indeed avoids uterine scarring and is likely protective against uterine rupture but is technically complex. This results in long surgical learning curves, poor dissemination of the surgery amongst centers worldwide, longer procedures and suboptimal surgical results which translate in decreased…
ClinicalTrials.gov, NCT06907732