Fetal Congenital AbnormalitiesFROSTNCT06907732
Fetoscopic Robotic Open Spina Bifida Treatment
A study testing Fetoscopic robotic open spina bifida closure in people with Fetal Congenital Abnormalities and Fetoscopy, run by Mount Sinai Hospital, Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Fetal Congenital Abnormalities, Fetoscopy, Fetal Surgery
- What is being tested?
- Fetoscopic robotic open spina bifida closure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- No sites listed yet
- Study dates
- Jul 2025to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 12Show fewer
- 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)
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Fetoscopic Robotic Open Spina Bifida Treatment - a Pilot Feasibility Study
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.
Read more
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
- Being tested
- Fetoscopic robotic open spina bifida closure
- Medical subject headings
- Neural Tube Defects, Spina Bifida Cystica
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fetoscopic robotic open spina bifida closureProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Fetoscopic robotic open spina bifida closure | Experimental | Participants in this single study arm will undergo fetoscopic robot-assisted open fetal spina bifida closure. Receives: Procedure: Fetoscopic robotic open spina bifida closure |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 hour postoperatively
Secondary outcomes (7)
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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: At 28 days of life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2025
- Study startJul 2025 (estimated)
- Primary completionJun 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fetal Congenital AbnormalitiesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Exploratory open-label surgical phase 1 study
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mount Sinai Hospital, Canada
- Sponsor type
- University, hospital or other
- Collaborators
- The Hospital for Sick Children
- Responsible party
- Principal investigator, Tim Van Mieghem, Mount Sinai Hospital, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06907732
- Sponsor's protocol ID
- FROST001
- Acronym
- FROST
- Status last verified
- Mar 2025
- First submitted
- 27 Feb 2025
- Last updated
- 7 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fetoscopic Robotic Open Spina Bifida Treatment - a Pilot Feasibility Study
- ClinicalTrials.gov ID
- NCT06907732
- Acronym / sponsor ID
- FROST / FROST001
- Conditions
- Fetal Congenital Abnormalities, Fetoscopy, Fetal Surgery, Robotic Surgical Procedure, Neural Tube Defect, Open Spina Bifida
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Mount Sinai Hospital, CanadaUniversity, hospital or other
- Collaborators
- The Hospital for Sick Children
- Study start
- Jul 2025 (estimated)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 2 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Exploratory open-label surgical phase 1 study
| Arm | Type | Receives |
|---|---|---|
| Fetoscopic robotic open spina bifida closure | Experimental | Procedure: Fetoscopic robotic open spina bifida closureParticipants in this single study arm will undergo fetoscopic robot-assisted open fetal spina bifida closure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fetoscopic robotic open spina bifida closureThree 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. | Procedure or surgery | Fetoscopic robotic open spina bifida closure |
Primary outcome
Number of patients with successful closure of the fetal spinal defect using a laparotomy-assisted fetoscopic robotic technique
Time frame: 1 hour postoperatively
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.
7 secondary outcomes
Number of patients with severe fetal complications
Time frame: At delivery
Number of patients with severe maternal complications
Time frame: At delivery
Number of patients experiencing preterm prelabor rupture of membranes
Time frame: At delivery
Number of patients experiencing preterm birth
Time frame: At delivery
Number of patients with a severe neonatal complication
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
Time frame: At 28 days of life
Number of infants with reversal of hindbrain herniation
Time frame: At 28 days of life
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2025.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Fetoscopic robotic open spina bifida closure in people with Fetal Congenital Abnormalities and Fetoscopy, run by Mount Sinai Hospital, Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 7 May 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tim Van Mieghem, MD, PhD (416 586 4800 ext. 6406, tim.vanmieghem@sinaihealth.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with successful closure of the fetal spinal defect using a laparotomy-assisted fetoscopic robotic technique (time frame: 1 hour postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2025.