Fetoscopic Neural Tube Defect Repair

Part of paid clinical trials in Portland, Oregon.

Sponsor
Oregon Health and Science University
Study ID
NCT06946563
Status
Recruiting
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Conditions

  • Neural Tube Defects
  • Spina Bifida

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Fetoscopic Neural Tube Defect Repair Devices — DEVICE
    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 Details

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.

Key Dates

Start date
Apr 1, 2023
Status verified
Apr 2025
Primary completion
Apr 30, 2028
Completion
Apr 30, 2033

Study Design

Enrollment
25 participants (estimated)

Arms

  • Arm: 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.

Primary Outcome Measure

Feasibility of minimally invasive surgical repair of NTD in fetus [ Time Frame: At the time of NTD repair surgery ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Oregon Health & Science UniversityPortlandOregon97239
Women's Health Research Unit
[email protected]
503-494-3666

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By research site
Oregon Health & Science University· Portland, OR

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