Fetoscopic Robotic Open Spina Bifida Treatment

NCT ID: NCT06907732

Last Updated: 2025-05-07

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-31
• Study Completion Date: 2027-12-31

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Fetoscopic robotic open spina bifida closure

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

Group Type: EXPERIMENTAL

Fetoscopic robotic open spina bifida closure

Intervention Type: 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.

Interventions

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.

Intervention Type: PROCEDURE

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

The Hospital for Sick Children

OTHER

Sponsor Role: collaborator

Mount Sinai Hospital, Canada

OTHER

Sponsor Role: lead

Responsible Party

Tim Van Mieghem

Maternal-Fetal Medicine specialist, Clinician-Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Tim Van Mieghem, MD, PhD

Role: CONTACT

tim.vanmieghem@sinaihealth.ca

416 586 4800 ext. 6406

Other Identifiers

FROST001

Identifier Type: -

Identifier Source: org_study_id