Fetoscopic Robotic Open Spina Bifida Treatment

NCT06907732 | Not Yet Recruiting DMC

• 1 other identifier: FROST001
• Study Type: interventional
• Target: 15
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Fetal Congenital Abnormalities; Fetoscopy; Fetal Surgery; Robotic Surgical Procedure; Neural Tube Defect; Open Spina Bifida

Outcome Measures

Primary Outcomes (1)

• 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.

  1 hour postoperatively

Secondary Outcomes (7)

• Number of patients with severe fetal complications

  At delivery

• Number of patients with severe maternal complications

  At delivery

• Number of patients experiencing preterm prelabor rupture of membranes

  At delivery

• Number of patients experiencing preterm birth

  At delivery

• Number of patients with a severe neonatal complication

  At discharge from Neonatal Intensive Care Unit or 28 days of life whichever comes last

Other Outcomes (4)

• Number of patients undergoing cesarean delivery

  At delivery

• Infant birthweight

  At delivery

• Number of neonates requiring respiratory support

  At discharge from Neonatal Intensive Care Unit

Study Arms (1)

Fetoscopic robotic open spina bifida closure

EXPERIMENTAL

Participants in this single study arm will undergo fetoscopic robot-assisted open fetal spina bifida closure.

Procedure: Fetoscopic robotic open spina bifida closure

Interventions

Fetoscopic robotic open spina bifida closure PROCEDURE

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.

Fetoscopic robotic open spina bifida closure

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Mount Sinai Hospital, Canada: lead
• The Hospital for Sick Children: collaborator

MeSH Terms

Conditions

Neural Tube Defects; Spina Bifida Cystica

Condition Hierarchy (Ancestors)

Nervous System Malformations; Nervous System Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Spinal Dysraphism

Central Study Contacts

Tim Van Mieghem, MD, PhD

CONTACT

416 586 4800; tim.vanmieghem@sinaihealth.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Maternal-Fetal Medicine specialist, Clinician-Investigator

Model Details: Exploratory open-label surgical phase 1 study

Study Record Dates

• First Submitted: February 27, 2025
• First Posted: April 2, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: May 7, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share