Clinical trial NCT06907732: Fetoscopic Robotic Open Spina Bifida Treatment
Official title: Fetoscopic Robotic Open Spina Bifida Treatment - a Pilot Feasibility Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Fetal Congenital Abnormalities
Fetoscopy
Fetal Surgery
Robotic Surgical Procedure
Neural Tube Defect
Open Spina Bifida
Lead sponsor: Mount Sinai Hospital, Canada
Sponsor class: OTHER
Collaborators: name: The Hospital for Sick Children
First posted: 2025-04-02
Enrollment: 15
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Exploratory open-label surgical phase 1 study
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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)

Primary outcomes:
measure: Number of patients with successful closure of the fetal spinal defect using a laparotomy-assisted fetoscopic robotic technique
timeFrame: 1 hour postoperatively
Secondary outcomes:
measure: Number of patients with severe fetal complications
timeFrame: At delivery
measure: Number of patients with severe maternal complications
timeFrame: At delivery
measure: Number of patients experiencing preterm prelabor rupture of membranes
timeFrame: At delivery
measure: Number of patients experiencing preterm birth
timeFrame: At delivery
measure: Number of patients with a severe neonatal complication
timeFrame: At discharge from Neonatal Intensive Care Unit or 28 days of life whichever comes last
measure: Number of infants requiring neonatal spinal scar revision
timeFrame: At 28 days of life
measure: Number of infants with reversal of hindbrain herniation
timeFrame: At 28 days of life
Other outcomes:
measure: Number of patients undergoing cesarean delivery
timeFrame: At delivery
measure: Infant birthweight
timeFrame: At delivery
measure: Number of neonates requiring respiratory support
timeFrame: At discharge from Neonatal Intensive Care Unit
measure: Duration of Neonatal Intensive Care Unit Stay
timeFrame: At discharge from Neonatal Intensive Care Unit
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