Neural Tube DefectsNTDNCT06946563
Fetoscopic Neural Tube Defect Repair
An observational study of Neural Tube Defects and Spina Bifida, run by Oregon Health and Science University at 1 site in United States.
Trial summary
This is a single-arm prospective study to record maternal and neonatal outcomes on subjects who undergo fetoscopic repair of Neural Tube Defects (NTD) at Oregon Health \& Science University (OHSU). Fetoscopic repair will take place between 24 weeks 0 days and 27 weeks 6 days gestation. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Neural Tube Defects, Spina Bifida
- What is being tested?
- Fetoscopic Neural Tube Defect Repair Devices
- Type of treatment
- Medical device
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2023to Apr 2033
- Phase
- Observational
- 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
Study population: Pregnant patients with a diagnosed Neural Tube Defect (NTD) electing to undergo fetoscopic NTD repair.
Who may be able to join
- Maternal age 18 years or older
- Capable of consenting for their own participation in the study
- Decision to have fetoscopic repair following counseling of all options
- Open spina bifida with the upper boundary between T1 and S1
- Gestational age between 24 0/7 to 26 6/7 weeks' gestation at the time of surgery
- Normal karyotype and/or normal chromosomal microarray by invasive testing. In the case of a microdeletion, microduplication, or variant of uncertain significant, the decision to include or exclude will be at the discretion of the Principal Investigators.
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- Absence of major cardiac anomalies confirmed by fetal echocardiogram
- Adequate social support throughout pregnancy
- Parental or guardian willingness to undergo follow-up evaluations of the child after birth
Who cannot join
- Multiple gestation
- Major fetal anomalies unrelated to the neural tube defect
- Kyphosis in fetus of 30 degrees or more as assessed by ultrasound or MRI
- Previous spontaneous singleton preterm birth prior to 37 weeks
- Presence of cervical cerclage at the time of surgery or history of cervical insufficiency
- Cervical length less than 20 mm by endovaginal ultrasound
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- Placenta previa or evidence of placental abruption
- Technical factors such as large uterine fibroids, uterine anomalies, or fetal membrane separation for which the risks of surgery are deemed to outweigh the benefits
- Maternal obesity precluding surgical access with a BMI > 45 or if the Principal Investigator determines the body habitus to be technically challenging
- Alloimmunization in pregnancy including Kell sensitization or a history of neonatal alloimmune thrombocytopenia
- Maternal HIV or Hepatitis B positive status. If the patient's HIV or Hepatitis B status is unknown, the patient must be tested and found to be negative prior to surgery
- Known Hepatitis C positivity. If the patient's Hepatitis C status is known, they do not need to be screened
- Maternal medical condition which is a contraindication to surgery or general anesthesia. This includes previous hysterotomy in the active segment of the uterus
- Maternal medical co-morbidities which would significantly increase the risk of spontaneous or iatrogenic preterm delivery
- Inability of the patient to comply with travel and follow-up requirements of the study
- Patient not meeting psychosocial criteria determined by fetal care social worked to comply with the medical care and plan for follow ups
- Participation in another interventional study that influences maternal and fetal morbidity and mortality
- Known history of hypersensitivity to collagen products or chondroitin materials
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Oregon Health & Science University
Portland, Oregon, 97239
Women's Health Research Unit, 503-494-3666, whru@ohsu.edu
About this study
Official title: Fetoscopic Neural Tube Defect Repair: Observational Pilot Study
This is a single-arm prospective study to record maternal and neonatal outcomes on subjects who undergo fetoscopic repair of Neural Tube Defects (NTD) at Oregon Health \& Science University (OHSU). Fetoscopic repair will take place between 24 weeks 0 days and 27 weeks 6 days gestation. Surgical, post-operative, delivery, and neonatal outcomes will be collected.
Read the detailed description
Patients undergoing fetoscopic NTD repair will be enrolled. Possible surgical approaches include completely percutaneous, laparotomy assisted, or mini laparotomy. Surgical approach will be determined by placental location, maternal body habitus, and shared decision making with the patient. The actual fetoscopic NTD repair is the same regardless of the surgical approach. Follow-up data collection will occur post-operatively, at delivery, NICU admission, and throughout childhood.
- Conditions
- Neural Tube Defects, Spina Bifida
- Being tested
- Fetoscopic Neural Tube Defect Repair Devices
- Keywords
- Fetal Surgery, Fetoscopy
- Medical subject headings
- Neural Tube Defects, Spinal Dysraphism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fetoscopic Neural Tube Defect Repair DevicesDevice
Also called Karl Storz Endoscopy-America, Inc., Richard Wolf Medical Instruments, Corp., Advanced Endoscopy Devices, Lexion Medical, LLC.
Fetoscopic NTD repair will be performed on enrolled participants. An incision will be made to gain exposure and access to the uterus. The amniotic cavity is entered using a needle to administer fetal anesthesia. Then, the initial trocar is inserted into the amniotic cavity. The major steps of the procedure are neural placode dissection, myofascial flaps creation, and closure of the neural tube defect.
| Study group | Role | What they receive |
|---|---|---|
| Fetoscopic Neural Tube Defect Repair | Individuals who undergo fetoscopic Neural Tube Defect (NTD) repair. Participants will undergo fetal surgery between 24 weeks 0 days and 27 weeks 6 days. Receives: Device: Fetoscopic Neural Tube Defect Repair Devices |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of minimally invasive surgical repair of NTD in fetus
Whether closure was achieved and whether the case was completed using the fetoscopic technique
Measured: At the time of NTD repair surgery
Secondary outcomes (1)
Chiari II malformation reversal
Reversal of hindbrain herniation based on ultrasound, fetal MRI, and postnatal MRI
Measured: Post-surgery ultrasound (weekly from surgery to delivery), post-surgery fetal MRI (4-6 weeks after surgery), and postnatal MRI (5-7 days after birth)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2025
- Study start1 Apr 2023
- Primary completionApr 2028 (estimated)
- Study completionApr 2033 (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 Oregon Health and Science UniversityThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Raphael Sun, Oregon Health and Science University
- Investigators
- Raphael Sun, MD, Principal investigator, Oregon Health and Science UniversityAndrew Chon, Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06946563
- Sponsor's protocol ID
- OHSU IRB 24397
- Acronym
- NTD
- Status last verified
- Apr 2025
- First submitted
- 18 Mar 2025
- Last updated
- 27 Apr 2025
- 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 27 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fetoscopic Neural Tube Defect Repair: Observational Pilot Study
- ClinicalTrials.gov ID
- NCT06946563
- Acronym / sponsor ID
- NTD / OHSU IRB 24397
- Conditions
- Neural Tube Defects, Spina Bifida
- Keywords
- Fetal Surgery, Fetoscopy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- Apr 2028 (estimated)
- Study completion
- Apr 2033 (estimated)
- First posted
- 27 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.
This is a single-arm prospective study to record maternal and neonatal outcomes on subjects who undergo fetoscopic repair of Neural Tube Defects (NTD) at Oregon Health \& Science University (OHSU). Fetoscopic repair will take place between 24 weeks 0 days and 27 weeks 6 days gestation. Surgical, post-operative, delivery, and neonatal outcomes will be collected.
Detailed description
Patients undergoing fetoscopic NTD repair will be enrolled. Possible surgical approaches include completely percutaneous, laparotomy assisted, or mini laparotomy. Surgical approach will be determined by placental location, maternal body habitus, and shared decision making with the patient. The actual fetoscopic NTD repair is the same regardless of the surgical approach. Follow-up data collection will occur post-operatively, at delivery, NICU admission, and throughout childhood.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fetoscopic Neural Tube Defect Repair | – | Device: Fetoscopic Neural Tube Defect Repair DevicesIndividuals who undergo fetoscopic Neural Tube Defect (NTD) repair. Participants will undergo fetal surgery between 24 weeks 0 days and 27 weeks 6 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Pregnant patients with a diagnosed Neural Tube Defect (NTD) electing to undergo fetoscopic NTD repair.
Key inclusion criteria (9 listed)
- Maternal age 18 years or older
- Capable of consenting for their own participation in the study
- Decision to have fetoscopic repair following counseling of all options
- Open spina bifida with the upper boundary between T1 and S1
- Gestational age between 24 0/7 to 26 6/7 weeks' gestation at the time of surgery
Key exclusion criteria (18 listed)
- Multiple gestation
- Major fetal anomalies unrelated to the neural tube defect
- Kyphosis in fetus of 30 degrees or more as assessed by ultrasound or MRI
- Previous spontaneous singleton preterm birth prior to 37 weeks
- Presence of cervical cerclage at the time of surgery or history of cervical insufficiency
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 Neural Tube Defect Repair DevicesAlso: Karl Storz Endoscopy-America, Inc., Richard Wolf Medical Instruments, Corp., Advanced Endoscopy Devices, Lexion Medical, LLC.Fetoscopic NTD repair will be performed on enrolled participants. An incision will be made to gain exposure and access to the uterus. The amniotic cavity is entered using a needle to administer fetal anesthesia. Then, the initial trocar is inserted into the amniotic cavity. The major steps of the procedure are neural placode dissection, myofascial flaps creation, and closure of the neural tube defect. | Device | Fetoscopic Neural Tube Defect Repair |
Primary outcome
Feasibility of minimally invasive surgical repair of NTD in fetus
Time frame: At the time of NTD repair surgery
Whether closure was achieved and whether the case was completed using the fetoscopic technique
1 secondary outcome
Chiari II malformation reversal
Time frame: Post-surgery ultrasound (weekly from surgery to delivery), post-surgery fetal MRI (4-6 weeks after surgery), and postnatal MRI (5-7 days after birth)
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 27 Apr 2025.
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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.
Raphael Sun, MD principal investigator
Oregon Health and Science University
Andrew Chon principal investigator
Oregon Health and Science University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neural Tube Defects and Spina Bifida, run by Oregon Health and Science University 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 9 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: looking for participants now, as of the sponsor's last update on 27 Apr 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?
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 Women's Health Research Unit Department of Ob/Gyn (503-494-3666, whru@ohsu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of minimally invasive surgical repair of NTD in fetus (time frame: At the time of NTD repair 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 27 Apr 2025.