Spina BifidaNCT03936322
Minimally Invasive Fetoscopic Regenerative Repair of Spina Bifida - A Pilot Study
A study testing Minimally invasive fetoscopic repair of MMC in people with Spina Bifida and Myelomeningocele, run by Rodrigo Ruano at 1 site in United States.
Trial summary
Researchers are studying a new minimally invasive technique (fetoscopic repair) for repair of spina bifida (MMC) during the second trimester of pregnancy. Researchers are trying to determine if this less invasive surgical approach will have less risk to the mother and at the same time adequate closure of the fetal… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Spina Bifida, Myelomeningocele, Neural Tube Defects
- What is being tested?
- Minimally invasive fetoscopic repair of MMC
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- 7 May 2019to 30 Jun 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Pregnant women - maternal age 18 years or older
- Gestational age at the time of the procedure between 19 0/7 weeks and 25 6/7 weeks
- Singleton pregnancy.
- MMC diagnosis with the upper boundary located between Thoracic 1 (T1) and Sacral
- 1 (S1).
- Evidence of hindbrain herniation (confirmed on MRI to have an Arnold-Chiari type II malformation).
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- Absence of chromosomal abnormalities and associated anomalies.
- Normal karyotype and/or normal chromosomal microarray (CMA) by invasive testing (amniocentesis or CVS). If there is a balanced translocation with normal CMA with no other anomalies the candidate can be included.
- Family has considered and declined the option of termination of the pregnancy at less than 24 weeks.
- Family meets psychosocial criteria (sufficient social support, ability to understand requirements for this study).
- Pregnant subject capable of consenting for their own participation in this study.
- Willingness to undergo an open MMC repair, if necessary
- Parental/guardian permission (informed consent) for follow up of child after birth.
Who cannot join
- Fetal anomaly unrelated to MMC.
- Multiple gestation
- Declined invasive testing for karyotype (amniocentesis or CVS)
- Severe kyphosis (defined as curvature of the spina (vertebras) higher than 30o degree measured by ultrasonography or magnetic resonance imaging).
- Increased risk for preterm labor including short cervical length (<2.0 cm), history of incompetent cervix with or without cerclage, and previous preterm birth.
- Placental abnormalities (previa, abruption, accreta) known at time of enrollment.
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- A body-mass index ≥40 at first prenatal visit.
- Contraindications to surgery including previous hysterotomy (whether from a previous classical cesarean, uterine anomaly such as an arcuate or bicornuate uterus, major myomectomy resection, or previous fetal surgery) in active uterine segment.
- Technical limitations precluding fetoscopic surgery, such as uterine fibroids, fetal membrane separation, uterine anomalies incompatible with fetoscopy.
- Amniotic Fluid Index (AFI) < 6 cm if deemed to be due to fetal anomaly, poor placental perfusion or function, or membrane rupture. Low amniotic fluid volume that responds to maternal hydration is not an exclusion.
- Maternal-fetal Rh isoimmunization, Kell sensitization or neonatal alloimmune thrombocytopenia affecting the current pregnancy.
- Maternal HIV, Hepatitis-B, Hepatitis-C status positive because of the increased risk of transmission to the fetus during maternal-fetal surgery. If the patients HIV or Hepatitis status is unknown, the patient must be tested and found to have negative results before enrollment.
- Maternal medical condition that is a contraindication to surgery or anesthesia.
- A score of ≥ 29 on the Beck Depression Inventory (BDI) at screening
- Maternal hypersensitivity to collagen
- Patient does not have a support person (i.e. Spouse, partner, mother) available to support the patient for the duration of the pregnancy.
- Inability to comply with the travel and follow-up requirements of the trial.
- Participation in another intervention study that influences maternal and fetal morbidity and mortality or participation in this trial in a previous pregnancy.
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Researchers are studying a new minimally invasive technique (fetoscopic repair) for repair of spina bifida (MMC) during the second trimester of pregnancy. Researchers are trying to determine if this less invasive surgical approach will have less risk to the mother and at the same time adequate closure of the fetal spina bifida defect.
- Conditions
- Spina Bifida, Myelomeningocele, Neural Tube Defects
- Being tested
- Minimally invasive fetoscopic repair of MMC
- Medical subject headings
- Spinal Dysraphism, Meningomyelocele, Neural Tube Defects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Minimally invasive fetoscopic repair of MMCDevice
Uses a technique to open your belly (skin, muscles and abdomen) without opening the uterus, except for a small puncture, to repair the fetal spina bifida defect during the second trimester of pregnancy.
| Study group | Role | What they receive |
|---|---|---|
| Pregnant women diagnosed with fetal myelomeningocele | Experimental | Women subjects who are pregnant and diagnosed with myelomeningocele (MMC), also known as fetal spina bifida or neural tube defect, will undergo a minimally invasive fetoscopic repair of MMC. Receives: Device: Minimally invasive fetoscopic repair of MMC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maternal Adverse Events
Total number of maternal adverse events
Measured: From time of surgery until delivery (up to 21 weeks)
Neonatal Adverse Events
Total number of neonatal adverse events
Measured: From the time of surgery until 28 days of life (up 25 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2019
- Study start7 May 2019
- Primary completion30 Jun 2024
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Spina BifidaStudies 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
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rodrigo Ruano
- Sponsor type
- University, hospital or other
- Collaborators
- Mayo Clinic
- Responsible party
- Sponsor-investigator, Rodrigo Ruano, University of Miami
- Investigators
- Rodrigo Ruano, M.D., Ph.D., Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03936322
- Sponsor's protocol ID
- 18-008622
- Status last verified
- Feb 2025
- First submitted
- 1 May 2019
- Last updated
- 24 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Minimally Invasive Fetoscopic Regenerative Repair of Spina Bifida - A Pilot Study
- ClinicalTrials.gov ID
- NCT03936322
- Acronym / sponsor ID
- 18-008622
- Conditions
- Spina Bifida, Myelomeningocele, Neural Tube Defects
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Rodrigo RuanoUniversity, hospital or other
- Collaborators
- Mayo Clinic
- Study start
- 7 May 2019 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 3 May 2019 (actual)
- Results
- Posted 24 Feb 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Researchers are studying a new minimally invasive technique (fetoscopic repair) for repair of spina bifida (MMC) during the second trimester of pregnancy. Researchers are trying to determine if this less invasive surgical approach will have less risk to the mother and at the same time adequate closure of the fetal spina bifida defect.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pregnant women diagnosed with fetal myelomeningocele | Experimental | Device: Minimally invasive fetoscopic repair of MMCWomen subjects who are pregnant and diagnosed with myelomeningocele (MMC), also known as fetal spina bifida or neural tube defect, will undergo a minimally invasive fetoscopic repair of MMC. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Pregnant women - maternal age 18 years or older
- Gestational age at the time of the procedure between 19 0/7 weeks and 25 6/7 weeks
- Singleton pregnancy.
- MMC diagnosis with the upper boundary located between Thoracic 1 (T1) and Sacral
- 1 (S1).
Key exclusion criteria (18 listed)
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 |
|---|---|---|
| Minimally invasive fetoscopic repair of MMCUses a technique to open your belly (skin, muscles and abdomen) without opening the uterus, except for a small puncture, to repair the fetal spina bifida defect during the second trimester of pregnancy. | Device | Pregnant women diagnosed with fetal myelomeningocele |
Primary outcome
Maternal Adverse Events
Time frame: From time of surgery until delivery (up to 21 weeks)
Total number of maternal adverse events
Neonatal Adverse Events
Time frame: From the time of surgery until 28 days of life (up 25 weeks)
Total number of neonatal adverse events
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Rodrigo Ruano, M.D., Ph.D. principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Minimally invasive fetoscopic repair of MMC in people with Spina Bifida and Myelomeningocele, run by Rodrigo Ruano at 1 site in United States.
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 13 inclusion and 18 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: finished, as of the sponsor's last update on 24 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Yes. Results are posted in the registry (first posted 24 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maternal Adverse Events (time frame: From time of surgery until delivery (up to 21 weeks)). The study lists 2 primary outcomes in all. 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 24 Feb 2025.