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Fetoscopic Surgery for Spina Bifida
Study Summary
This trial will test two different ways to operate on fetuses with myelomeningocele (a birth defect where the spinal cord doesn't form properly). One approach goes through the mother's skin (percutaneous), and the other goes through the mother's belly (laparotomy/uterine exteriorization).
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- I want to have surgery for my baby's spina bifida before birth at this hospital.The mother has a medical condition that makes surgery or anesthesia unsafe.I can come back for check-ups at 12, 24, 30, 48, and 60 months.You have diabetes that requires insulin before becoming pregnant.My test results confirm a balanced karyotype, acceptable through FISH if I'm 24 weeks along or more.You have been diagnosed with Hepatitis-C. If you don't know your status, you don't need to get tested.You don't have someone to support you during the study, like a spouse, partner, or parent.You have placenta previa or placental abruption.Your cervix is shorter than 25 millimeters when measured by ultrasound.My uterus shape is not typical and considered unsafe for surgery.I do not have HIV or Hepatitis-B, or I have tested negative for them.I can't meet the travel or follow-up needs of the study.I am 18 years old or older.I am considered capable of consenting to the procedure and have a good support system.You have a body mass index (BMI) of 35 or higher, which means you are very overweight.I have a spinal defect from T1 to S1 with brain tissue protrusion, confirmed by MRI and ultrasound.You have a medical history related to blood type issues during pregnancy or birth.I have high blood pressure during pregnancy, increasing my risk of early delivery.You are allergic to nickel.My unborn baby has a diagnosed condition unrelated to spinal issues.A baby in the womb has a spine that curves too much.I have a cervical stitch or a history of weak cervix.You have given birth to a single baby before 37 weeks without any medical intervention.I have a large fibroid or a unique uterine condition.You do not meet the mental and emotional requirements after being evaluated by a social worker.You are allergic to bovine collagen or chondroitin materials.A pediatric neurologist has given you a good review.
- Group 1: Fetoscopic repair
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
How many participants have joined this research project thus far?
"Affirmative. The clinical trial is still hoping to enrol participants, as indicated on the clinicaltrials.gov website – which was first published in November 2018 and updated last year. A total of 12 patients need to be enrolled from two separate sites."
Are there any open vacancies in this clinical experiment?
"This trial is still open to participants, with the original posting date on November 2nd 2018 and last update on November 11th 2019. This information can be found on clinicaltrials.gov."
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