Neural Tube DefectsNCT05672849
Safety and Efficacy of Devices Used in Fetoscopic Neural Tube Defect Repair Cases
A study testing Modified Surgical Instruments/Devices (Sheaths and Irrigator) in people with Neural Tube Defects, run by Michael A Belfort at 1 site in United States.
Trial summary
The purpose of the study is to evaluate the safety and efficacy of devices used in patients undergoing fetoscopic neural tube defect repair. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Neural Tube Defects
- What is being tested?
- Modified Surgical Instruments/Devices (Sheaths and Irrigator)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Nov 2022to 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
- Patients who elect to undergo fetoscopic neural tube defect repair
Who cannot join
- Patients who do not elect to undergo fetoscopic neural tube defect repair
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
Texas Childrens Hospital - Pavilion for Women
Houston, Texas, 77030
Michael A Belfort, MD, 832-826-7375, belfort@bcm.edu
Becky Johnson, 832-826-7451, rj2@bcm.edu
About this study
The purpose of the study is to evaluate the safety and efficacy of devices used in patients undergoing fetoscopic neural tube defect repair.
Read the detailed description
All patients who choose to undergo fetoscopic neural tube defect repair at Texas Children's Fetal Center will be offered participation in this research study by study investigators. Description of study rationale and design and a focused interview by the study coordinator to afford potential participants a formal opportunity to examine what they have learned about the research study in the course of their evaluation and discuss how they feel about enrolling in the research study. Once the patient is deemed eligible the informed consent process will be reviewed. If patients elect to participate in the study, informed consent will be obtained, and patients provided a copy of the signed consent.
Fetoscopic Procedure: The fetoscopic open neural tube defect repair procedure will be performed with the same technique in this protocol as the investigators did in the previous protocols under this IDE (NCT02230072 and NCT03794011) in terms of exteriorization of the uterus, preparation for the fetoscopic repair and repair of the open neural tube defect. This involves release of the placode, dissection of the surrounding skin, development of myofascial flaps on either side of the defect, placement of a patch to be laid on top of the placode prior to closure of the myofascial flaps, suture of the flaps over the freed placode and patch and attempted primary closure of the defect using available skin. If necessary, the surgeons will use relaxing incisions or a skin patch to provide additional mobility to the skin to be closed over the defect. If the surgeons are unable to close the skin primarily despite best fetoscopic efforts, the option of performing/completing the repair as an open procedure exists and will be offered to the subject.
Follow-Up: The investigators will follow patients for the immediate post-procedure period (until they leave the OR).
- Conditions
- Neural Tube Defects
- Being tested
- Modified Surgical Instruments/Devices (Sheaths and Irrigator)
- Keywords
- myelomeningocele, MMC, NTD, neural tube defect, spina bifida
- Medical subject headings
- Neural Tube Defects, Meningomyelocele, Spinal Dysraphism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified Surgical Instruments/Devices (Sheaths and Irrigator)Device
Patients who choose to undergo fetoscopic surgery will be offered participation in this study. All patients will undergo a fetoscopic repair of the fetal open neural tube defect with the use of the modified devices in this study.
| Study group | Role | What they receive |
|---|---|---|
| Modified Devices in fetoscopic NTD repair | Experimental | Single arm study. All patients will undergo fetoscopic NTD repair with the use of the modified devices. Receives: Device: Modified Surgical Instruments/Devices (Sheaths and Irrigator) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of adverse events
Number of adverse events associated with the investigational device
Measured: Immediate Post-Procedure period (until the leave the OR)
Number of device defects, malfunctions, or failures
Number of device defects, malfunctions, or failures and whether the device performed as intended.
Measured: Immediate Post-Procedure period (until the leave the OR)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2023
- Study start14 Nov 2022
- Primary completionDec 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 Neural Tube DefectsStudies 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Michael A Belfort
- Sponsor type
- University, hospital or other
- Collaborators
- Baylor College of Medicine
- Responsible party
- Sponsor-investigator, Michael A Belfort, Baylor College of Medicine
- Investigators
- Michael A Belfort, MD, Principal investigator, Baylor College of Medicine and Texas Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05672849
- Sponsor's protocol ID
- H-51509
- Status last verified
- Dec 2025
- First submitted
- 28 Nov 2022
- Last updated
- 15 Dec 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 15 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Devices Used in Fetoscopic Neural Tube Defect Repair Cases
- ClinicalTrials.gov ID
- NCT05672849
- Acronym / sponsor ID
- H-51509
- Conditions
- Neural Tube Defects
- Keywords
- myelomeningocele, MMC, NTD, neural tube defect, spina bifida
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Michael A BelfortUniversity, hospital or other
- Collaborators
- Baylor College of Medicine
- Study start
- 14 Nov 2022 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 5 Jan 2023 (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 the study is to evaluate the safety and efficacy of devices used in patients undergoing fetoscopic neural tube defect repair.
Detailed description
All patients who choose to undergo fetoscopic neural tube defect repair at Texas Children's Fetal Center will be offered participation in this research study by study investigators. Description of study rationale and design and a focused interview by the study coordinator to afford potential participants a formal opportunity to examine what they have learned about the research study in the course of their evaluation and discuss how they feel about enrolling in the research study. Once the patient is deemed eligible the informed consent process will be reviewed. If patients elect to participate in the study, informed consent will be obtained, and patients provided a copy of the signed consent.
Fetoscopic Procedure: The fetoscopic open neural tube defect repair procedure will be performed with the same technique in this protocol as the investigators did in the previous protocols under this IDE (NCT02230072 and NCT03794011) in terms of exteriorization of the uterus, preparation for the fetoscopic repair and repair of the open neural tube defect. This involves release of the placode, dissection of the surrounding skin, development of myofascial flaps on either side of the defect, placement of a patch to be laid on top of the placode prior to closure of the myofascial flaps, suture of the flaps over the freed placode and patch and attempted primary closure of the defect using available skin. If necessary, the surgeons will use relaxing incisions or a skin patch to provide additional mobility to the skin to be closed over the defect. If the surgeons are unable to close the skin primarily despite best fetoscopic efforts, the option of performing/completing the repair as an open procedure exists and will be offered to the subject.
Follow-Up: The investigators will follow patients for the immediate post-procedure period (until they leave the OR).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Modified Devices in fetoscopic NTD repair | Experimental | Device: Modified Surgical Instruments/Devices (Sheaths and Irrigator)Single arm study. All patients will undergo fetoscopic NTD repair with the use of the modified devices. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients who elect to undergo fetoscopic neural tube defect repair
Key exclusion criteria (1 listed)
- Patients who do not elect to undergo fetoscopic neural tube defect repair
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 |
|---|---|---|
| Modified Surgical Instruments/Devices (Sheaths and Irrigator)Patients who choose to undergo fetoscopic surgery will be offered participation in this study. All patients will undergo a fetoscopic repair of the fetal open neural tube defect with the use of the modified devices in this study. | Device | Modified Devices in fetoscopic NTD repair |
Primary outcome
Number of adverse events
Time frame: Immediate Post-Procedure period (until the leave the OR)
Number of adverse events associated with the investigational device
Number of device defects, malfunctions, or failures
Time frame: Immediate Post-Procedure period (until the leave the OR)
Number of device defects, malfunctions, or failures and whether the device performed as intended.
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 15 Dec 2025.
Related trials for Neural Tube Defects
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First-Trimester Screening of Open Neural Tube Defects Using Biometrics and Maternal Serum Markers
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Patch vs. No Patch Fetoscopic Meningomyelocele Repair Study
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Folic Acid Salt Study (FISFA Zambia)
Folate Deficiency, Neural Tube Defects
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Investigation of Surgical Sectioning of the Filum Terminale in Treating Occult Tethered Cord Syndrome Patients
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In-Utero Endoscopic Correction of Spina Bifida
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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.
Michael A Belfort, MD principal investigator
Baylor College of Medicine and Texas Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Modified Surgical Instruments/Devices (Sheaths and Irrigator) in people with Neural Tube Defects, run by Michael A Belfort 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 1 inclusion and 1 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 15 Dec 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 Michael A Belfort, MD (832-826-7375, belfort@bcm.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of adverse events (time frame: Immediate Post-Procedure period (until the leave the OR)). 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 15 Dec 2025; AzTrials last refreshed its copy on 8 Nov 2026.