Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 9:44 PM
Ignite Modification Date:
2025-12-24 @ 9:44 PM
NCT ID:
NCT06907732
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 22-26 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 infant benefits - particularly with regards to motor function.
The investigators have developed a fetoscopic robotic approach where they leverage the dexterity of robotic instruments to perform these complex surgeries. The team expects that this will result in easier and faster procedures with better surgical outcomes and therefore fetal benefits comparable to open fetal surgery, while at the same time avoiding the need for hysterotomy.
In this prospective exploratory phase 1 study, the investigators propose to assess the feasibility of such a robotic approach, as developed and trained on a high-fidelity phantom, in 15 patients. The research team will collect maternal and fetal safety and efficacity data to inform later studies.
Study:
NCT06907732
Study Brief:
Protocol Section:
NCT06907732