MedTrace Logo

Fetoscopic Neural Tube Defect Repair

NCT06946563 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 25

Last updated 2025-04-27

No results posted yet for this study

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. Surgical, post-operative, delivery, and neonatal outcomes will be collected.

Conditions

  • Neural Tube Defects
  • Spina Bifida

Interventions

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.

Sponsors & Collaborators

  • Oregon Health and Science University

    lead OTHER

Principal Investigators

  • Raphael Sun, MD · Oregon Health and Science University

  • Andrew Chon · Oregon Health and Science University

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-04-01
Primary Completion
2028-04-30
Completion
2033-04-30
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06946563 on ClinicalTrials.gov