An interventional study of Fetoscopic robotic open spina bifida closure in Fetal Congenital Abnormalities, Fetoscopy and Fetal Surgery, sponsored by Mount Sinai Hospital, Canada. Not yet recruiting. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-05-07.
Sponsored by Mount Sinai Hospital, Canada · Not applicable, Interventional, and Treatment
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.
47 studies on the registry are indexed under Neural Tube Defects; 9 are open to participants now.
This study's planned enrollment of 15 is below the median of 47 across 26 interventional studies indexed under Neural Tube Defects.
Browse Neural Tube Defects studies →Mount Sinai Hospital, Canada is the lead sponsor of 158 studies on the registry; 32 are open to participants now.
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A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
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The human immunodeficiency virus, which weakens the immune system.
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants in this single study arm will undergo fetoscopic robot-assisted open fetal spina bifida closure.
Procedure: Fetoscopic robotic open spina bifida closure
Three 9 mm laparoscopic trocars will be inserted into the uterus after the uterus is exteriorized through a maternal laparotomy. Partial amniotic carbon dioxide insufflation will be done with heated humidified gas. Using a surgical robot, multilayer closure of the lesion will be performed, similar to our current protocol in open fetal spina bifida closure (durapatch, myofascial flap, skin closure). Pre- and postoperative management will be similar to our current open fetal surgery protocol. Delivery will be by cesarean section, either when spontaneous labor occurs or at 39 weeks, whichever presents first.
Number of patients with successful closure of the fetal spinal defect using a laparotomy-assisted fetoscopic robotic technique
Number of patients who underwent successful closure of the fetal spinal defect in layers using a laparotomy-assisted fetoscopic robotic technique without conversion to hysterotomy.
Time frame: 1 hour postoperatively
Number of patients with severe fetal complications
Number of patients with severe fetal complications defined as a composite of intraoperative fetal heart rate decelerations requiring intervention and/or intra- or postoperative fetal death.
Time frame: At delivery
Number of patients with severe maternal complications
Number of severe maternal complications defined as a composite outcome including: need for maternal blood transfusion for hemorrhage, placental abruption, chorioamnionitis as assessed on placental pathology, ileus, wound infection or dehiscence, other serious maternal morbidity requiring admission to an intensive care unit, scar dehiscence or rupture at the time of delivery
Time frame: At delivery
Number of patients experiencing preterm prelabor rupture of membranes
Incidence of Preterm Prelabor Rupture of Membranes (PPROM). Gestational age at PPROM (in weeks' gestation) will also be recorded.
Time frame: At delivery
Number of patients experiencing preterm birth
Gestational age at birth will be recorded in weeks (in weeks) and categorized as \<28, \<32 and \<37 weeks' gestation. Number of patients experiencing preterm birth is number of those delivering prior to 37 weeks' gestation.
Time frame: At delivery
Number of patients with a severe neonatal complication
Number of patient with a severe neonatal complication defined as a composite of either: Neonatal death, death before discharge from the neonatal intensive care unit (NICU) or severe neonatal morbidity defined as the presence of at least one of the following: chronic lung disease, patent ductus arteriosus needing medical therapy or surgical closure, necrotising enterocolitis grade 2 or higher, retinopathy of prematurity stage 3 or higher or severe cerebral injury defined as intraventricular hemorrhage grade 3 or higher or cystic periventricular leukomalacia grade 2 or higher.
Time frame: At discharge from Neonatal Intensive Care Unit or 28 days of life whichever comes last
Number of infants requiring neonatal spinal scar revision
Number of infants requiring neonatal spinal scar revision within 28 days of birth
Time frame: At 28 days of life
Number of infants with reversal of hindbrain herniation
Number of infants with reversal of hindbrain herniation (chiari II malformation) as assessed by MRI during pregnancy or within first 28 days of life.
Time frame: At 28 days of life
Number of patients undergoing cesarean delivery
Mode of delivery will be recorded as cesarean delivery, spontaneous vaginal delivery or assisted vaginal delivery. Number of patients undergoing cesarean delivery will be reported
Time frame: At delivery
Infant birthweight
Infant birthweight measured in grams
Time frame: At delivery
Number of neonates requiring respiratory support
Number of neonates requiring respiratory support defined as continuous positive airway pressure (CPAP) or invasive ventilation.
Time frame: At discharge from Neonatal Intensive Care Unit
Duration of Neonatal Intensive Care Unit Stay
Length of initial neonatal stay in the Neonatal Intensive Care unit, measured in days.
Time frame: At discharge from Neonatal Intensive Care Unit
No study locations are listed for this record.
Plan to share: Yes
No publications or documents are linked to this record.
Start is estimated for Jul 2025; primary completion for Jun 2027, 23 months later.
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This study is not yet recruiting, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
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Mount Sinai Hospital, Canada →