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Procedure
Fetoscopic Surgery for Spina Bifida
N/A
Recruiting
Led By Ruben Quintero, MD
Research Sponsored by USFetus
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Maternal age ≥18 years
Myelomeningocele (including myeloschisis) at level T1 through S1 with hindbrain herniation confirmed by MRI and ultrasonography
Must not have
Bicornuate uterus or any other uterine malformation deemed unsafe for surgery by the PI
Maternal HIV or Hepatitis-B status positive; unknown status requires testing and negative results before enrollment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at time of surgery until delivery, up to 21 weeks
Awards & highlights
No Placebo-Only Group
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).
Who is the study for?
This trial is for pregnant women over 18 with a fetus diagnosed with myelomeningocele, between 19-27 weeks' gestation. They must be able to stay near Wellington or Pasadena for the pregnancy and delivery, and return for follow-ups. Exclusions include multiple pregnancies, certain health conditions like HIV/Hepatitis-B, obesity (BMI of 35+), nickel allergy, pregestational diabetes, uterine anomalies, previous early deliveries.
What is being tested?
The study tests a fetoscopic surgical technique versus traditional surgery to correct fetal myelomeningocele before birth. The percutaneous approach is used if the placenta is at the back; otherwise laparotomy/uterine exteriorization can be done regardless of placental location.
What are the potential side effects?
Potential side effects are not explicitly listed but may include typical risks associated with surgeries such as infection risk at the incision site, bleeding complications during or after surgery, possible adverse reactions to anesthesia or materials used in surgery.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Select...
I have a spinal defect from T1 to S1 with brain tissue protrusion, confirmed by MRI and ultrasound.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My uterus shape is not typical and considered unsafe for surgery.
Select...
I do not have HIV or Hepatitis-B, or I have tested negative for them.
Select...
I can't meet the travel or follow-up needs of the study.
Select...
My unborn baby has a diagnosed condition unrelated to spinal issues.
Select...
I have a cervical stitch or a history of weak cervix.
Select...
I have a large fibroid or a unique uterine condition.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at time of surgery until delivery, up to 21 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at time of surgery until delivery, up to 21 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Rate of successful in-utero fetoscopic myelomeningocele closures using either laparotomy or percutaneous techniques
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Fetoscopic repairExperimental Treatment1 Intervention
Find a Location
Who is running the clinical trial?
Wellington HospitalOTHER_GOV
8 Previous Clinical Trials
1,343 Total Patients Enrolled
University of Southern CaliforniaOTHER
944 Previous Clinical Trials
1,604,633 Total Patients Enrolled
USFetusLead Sponsor
1 Previous Clinical Trials
110 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.
Research Study Groups:
This trial has the following groups:- Group 1: Fetoscopic repair
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- 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.
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