Neural Tube DefectsNCT04362592
In-Utero Endoscopic Correction of Spina Bifida
A study testing In Utero Endoscopic Correction of Myelomeningocele IDE - Percutaneous Technique and In Utero Endoscopic Correction of Myelomeningocele IDE - Laparotomy/Uterine Exteriorization Technique in people with Neural Tube Defects and Spina Bifida, run by University of Southern California at 2 sites in United States.
Trial summary
The purpose of this study is to evaluate the feasibility and effectiveness of performing fetoscopic surgical correction of fetal spina bifida. Two surgical approaches will be utilized: the percutaneous technique versus the laparotomy/uterine exteriorization technique. Read more about this study
- Who is it for?
- Ages 18 to 52 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Neural Tube Defects, Spina Bifida, Myelomeningocele
- What is being tested?
- In Utero Endoscopic Correction of Myelomeningocele IDE - Percutaneous Technique and In Utero Endoscopic Correction of Myelomeningocele IDE - Laparotomy/Uterine Exteriorization Technique
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 2 sitesUnited States
- Study dates
- 2 Nov 2018to 31 Dec 2031
- 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 to 52 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Myelomeningocele (including myeloschisis) at level T1 through S1 with hindbrain herniation. Lesion level and hindbrain herniation will be confirmed by MRI and ultrasonography.
- Maternal age ≥18 years.
- Gestational age of 19 to 27 6/7 weeks' gestation as determined by clinical information and evaluation of first ultrasound.
- Balanced karyotype and/or normal mircoarray with written confirmation of culture results. Results by fluorescence in situ hybridization (FISH) will be acceptable if the patient is at 24 weeks or more.
- Positive evaluation of social work consult indicating the patient is capable of consenting to the procedure and has the appropriate social support system to participate in the study.
- Positive evaluation from pediatric neurology consult.
- Willing to return to our center, or to a multi-disciplinary spina bifida clinic closer to their home for the 6, 12, 24, 30, 48, and 60 months follow-up evaluations.
Who cannot join
- Multiple gestation
- Insulin-dependent pregestational diabetes
- Presence of a fetal anomaly not related to Chiari II Malformation. A fetal echocardiogram will be conducted before surgery and if the finding is abnormal, the patient will be excluded.
- Fetal kyphosis of 30 degrees or more, assessed by ultrasound or MRI.
- Presence of uterine cervical cerclage or history of incompetent cervix.
- Placenta previa or placental abruption.
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- Short cervix < 25 mm measured by cervical ultrasound.
- Obesity as defined by body mass index (BMI) of 40 or greater.
- History of previous spontaneous singleton delivery prior to 37 weeks.
- Maternal-fetal Rh isoimmunization, Kell sensitization or a history of neonatal alloimmune thrombocytopenia.
- Maternal HIV or Hepatitis-B status positive because of the increased risk of transmission to the fetus during maternal-fetal surgery. If the patient's HIV or Hepatitis B status is unknown, the patient must be tested and found to have negative results before she can be enrolled.
- Known Hepatitis-C positivity. If the patient's Hepatitis C status is unknown, she does not need to be screened.
- Uterine anomaly such as large (greater than 6 cm) fibroids, cervical fibroids or multiple fibroids or Mullerian duct abnormality.
- Other maternal medical condition which is a contraindication to surgery or anesthesia.
- Patient does not have a support person (e.g., husband, partner, parents).
- Inability to comply with the travel and follow-up requirements of the study.
- Patient does not meet psychosocial criteria as determined by the social worker evaluation.
- Participation in another intervention study that influences maternal and fetal morbidity and mortality.
- Maternal hypertension as determined by the investigator, which would increase the risk of preeclampsia or preterm delivery (including, but not limited to: uncontrolled hypertension, chronic hypertension with end organ damage and new onset hypertension in current pregnancy).
- Bicornuate uterus or any other uterine malformation the PI decides is not safe for surgery.
- Nickel allergy.
- Maternal request to undergo open fetal surgery for the antenatal correction of OSB at our institution primarily or after failed fetoscopic approach.
- Known maternal hypersensitivity to bovine collagen or chondroitin materials.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Hollywood Presbyterian Medical Center
Los Angeles, California, 90027
Wellington Regional Medical Center
Wellington, Florida, 33141
About this study
Official title: In-Utero Endoscopic Correction of Spina Bifida: Laparotomy-Assisted or Percutaneous
The purpose of this study is to evaluate the feasibility and effectiveness of performing fetoscopic surgical correction of fetal spina bifida. Two surgical approaches will be utilized: the percutaneous technique versus the laparotomy/uterine exteriorization technique.
- Conditions
- Neural Tube Defects, Spina Bifida, Myelomeningocele
- Being tested
- In Utero Endoscopic Correction of Myelomeningocele IDE - Percutaneous Technique, In Utero Endoscopic Correction of Myelomeningocele IDE - Laparotomy/Uterine Exteriorization Technique
- Medical subject headings
- Neural Tube Defects, Spinal Dysraphism, Meningomyelocele
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
In Utero Endoscopic Correction of Myelomeningocele IDE - Percutaneous TechniqueDevice
The percutaneous approach uses endoscopes through a closed maternal abdomen and closed uterus to perform the spina bifida correction.
In Utero Endoscopic Correction of Myelomeningocele IDE - Laparotomy/Uterine Exteriorization TechniqueDevice
The laparotomy/uterine exteriorization technique uses endoscopes through an open abdomen and closed, exteriorized uterus to perform the spina bifida correction.
| Study group | Role | What they receive |
|---|---|---|
| Percutaneous Technique | Experimental | The percutaneous technique uses endoscopic scopes through the maternal skin and uterus to perform the surgery. A variation of the percutaneous technique is the mini-laparotomy technique, which uses an endoscopic scope through an incision on the abdomen, smaller than a laparotomy ("mini-laparotomy"), and smaller endoscopic scopes through the maternal skin and uterus to perform the surgery. Receives: Device: In Utero Endoscopic Correction of Myelomeningocele IDE - Percutaneous Technique |
| Laparotomy/Uterine Exteriorization Technique | Experimental | The laparotomy/uterine exteriorization technique consists of performing a laparotomy (incision into the abdominal cavity), exteriorizing the uterus, and using endoscopic scopes through the uterus to perform the correction. Receives: Device: In Utero Endoscopic Correction of Myelomeningocele IDE - Laparotomy/Uterine Exteriorization Technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ability to perform the endoscopic procedure
Successful fetoscopic closure of the defect
Measured: At time of surgery
Secondary outcomes (1)
Chiari II malformation reversal
Reversal of hindbrain herniation on ultrasound and MRI
Measured: Prior to delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2020
- Study start2 Nov 2018
- Primary completion29 Jun 2025
- Study completion31 Dec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neural Tube DefectsStudies of the same condition, open and under way.
- More trials run by University of Southern CaliforniaThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Collaborators
- USFetus
- Responsible party
- Principal investigator, Ramen Chmait, University of Southern California
- Investigators
- Ruben Quintero, MD, Principal investigator, US FetusRamen Chmait, MD, Principal investigator, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04362592
- Sponsor's protocol ID
- HS-05-00374
- Status last verified
- Apr 2026
- First submitted
- 24 Mar 2020
- Last updated
- 4 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In-Utero Endoscopic Correction of Spina Bifida: Laparotomy-Assisted or Percutaneous
- ClinicalTrials.gov ID
- NCT04362592
- Acronym / sponsor ID
- HS-05-00374
- Conditions
- Neural Tube Defects, Spina Bifida, Myelomeningocele
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Collaborators
- USFetus
- Study start
- 2 Nov 2018 (actual)
- Primary completion
- 29 Jun 2025 (actual)
- Study completion
- 31 Dec 2031 (estimated)
- First posted
- 27 Apr 2020 (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.
The purpose of this study is to evaluate the feasibility and effectiveness of performing fetoscopic surgical correction of fetal spina bifida. Two surgical approaches will be utilized: the percutaneous technique versus the laparotomy/uterine exteriorization technique.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Percutaneous Technique | Experimental | Device: In Utero Endoscopic Correction of Myelomeningocele IDE - Percutaneous TechniqueThe percutaneous technique uses endoscopic scopes through the maternal skin and uterus to perform the surgery. A variation of the percutaneous technique is the mini-laparotomy technique, which uses an endoscopic scope through an incision on the abdomen, smaller than a laparotomy ("mini-laparotomy"), and smaller endoscopic scopes through the maternal skin and uterus to perform the surgery. |
| Laparotomy/Uterine Exteriorization Technique | Experimental | Device: In Utero Endoscopic Correction of Myelomeningocele IDE - Laparotomy/Uterine Exteriorization TechniqueThe laparotomy/uterine exteriorization technique consists of performing a laparotomy (incision into the abdominal cavity), exteriorizing the uterus, and using endoscopic scopes through the uterus to perform the correction. |
Who may qualify
- Ages
- 18 to 52 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Myelomeningocele (including myeloschisis) at level T1 through S1 with hindbrain herniation. Lesion level and hindbrain herniation will be confirmed by MRI and ultrasonography.
- Maternal age ≥18 years.
- Gestational age of 19 to 27 6/7 weeks' gestation as determined by clinical information and evaluation of first ultrasound.
- Balanced karyotype and/or normal mircoarray with written confirmation of culture results. Results by fluorescence in situ hybridization (FISH) will be acceptable if the patient is at 24 weeks or more.
- Positive evaluation of social work consult indicating the patient is capable of consenting to the procedure and has the appropriate social support system to participate in the study.
Key exclusion criteria (23 listed)
- Multiple gestation
- Insulin-dependent pregestational diabetes
- Presence of a fetal anomaly not related to Chiari II Malformation. A fetal echocardiogram will be conducted before surgery and if the finding is abnormal, the patient will be excluded.
- Fetal kyphosis of 30 degrees or more, assessed by ultrasound or MRI.
- Presence of uterine cervical cerclage or history of incompetent cervix.
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 |
|---|---|---|
| In Utero Endoscopic Correction of Myelomeningocele IDE - Percutaneous TechniqueThe percutaneous approach uses endoscopes through a closed maternal abdomen and closed uterus to perform the spina bifida correction. | Device | Percutaneous Technique |
| In Utero Endoscopic Correction of Myelomeningocele IDE - Laparotomy/Uterine Exteriorization TechniqueThe laparotomy/uterine exteriorization technique uses endoscopes through an open abdomen and closed, exteriorized uterus to perform the spina bifida correction. | Device | Laparotomy/Uterine Exteriorization Technique |
Primary outcome
Ability to perform the endoscopic procedure
Time frame: At time of surgery
Successful fetoscopic closure of the defect
1 secondary outcome
Chiari II malformation reversal
Time frame: Prior to delivery
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 4 May 2026.
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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.
Ruben Quintero, MD principal investigator
US Fetus
Ramen Chmait, MD principal investigator
University of Southern California
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing In Utero Endoscopic Correction of Myelomeningocele IDE - Percutaneous Technique and In Utero Endoscopic Correction of Myelomeningocele IDE - Laparotomy/Uterine Exteriorization Technique in people with Neural Tube Defects and Spina Bifida, run by University of Southern California at 2 sites 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 7 inclusion and 23 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: under way, not looking for participants, as of the sponsor's last update on 4 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
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?
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?
Ability to perform the endoscopic procedure (time frame: At time of surgery). 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 4 May 2026.