Fetoscopic Robotic Open Spina Bifida Treatment (FROST)

Mount Sinai Hospital, Canada

Status

Not yet enrolling

Conditions

Open Spina Bifida

Fetoscopy

Neural Tube Defect

Robotic Surgical Procedure

Fetal Surgery

Fetal Congenital Abnormalities

Treatments

Procedure: Fetoscopic robotic open spina bifida closure

Study type

Interventional

Funder types

Other

Identifiers

NCT06907732

FROST001

Details and patient eligibility

About

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.

Enrollment

15 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)