Fetoscopic Neural Tube Defect Repair (NTD)

April 20, 2025 updated by: Raphael Sun, Oregon Health and Science University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
25

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Women's Health Research Unit Department of OB/Gyn
  • Phone Number: 503-494-3666
  • Email: whru@ohsu.edu

Study Locations

  • United States
    • Oregon
      • Portland, Oregon, United States, 97239
        • Recruiting
        • Oregon Health & Science University
        • Contact:
          • Women's Health Research Unit
          • Phone Number: 503-494-3666
          • Email: whru@ohsu.edu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Pregnant patients with a diagnosed Neural Tube Defect (NTD) electing to undergo fetoscopic NTD repair.

Description

Inclusion Criteria:

  • 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.
  • 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

Exclusion Criteria:

  • 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
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Device: Fetoscopic Neural Tube Defect Repair Devices
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.
Other Names:
  • Richard Wolf Medical Instruments, Corp.
  • Karl Storz Endoscopy-America, Inc.
  • Cook Medical, Inc.
  • Lexion Medical, LLC.
  • Advanced Endoscopy Devices
  • Becton Dickinson Visitec Pro
  • TERUMO Pinnacle
  • Integra LifeSciences
  • Applied Medical Resources

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
At the time of NTD repair surgery

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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)
Reversal of hindbrain herniation based on ultrasound, fetal MRI, and postnatal MRI
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Oregon Health and Science University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Raphael Sun, MD, Oregon Health and Science University
  • Principal Investigator: Andrew Chon, Oregon Health and Science University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2033

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 18, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 20, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 27, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 27, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 20, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • OHSU IRB 24397

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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