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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 below
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I am 18 years old or older.
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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:
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My uterus shape is not typical and considered unsafe for surgery.
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I do not have HIV or Hepatitis-B, or I have tested negative for them.
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I can't meet the travel or follow-up needs of the study.
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My unborn baby has a diagnosed condition unrelated to spinal issues.
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I have a cervical stitch or a history of weak cervix.
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I have a large fibroid or a unique uterine condition.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at time of surgery until delivery, up to 21 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and at time of surgery until delivery, up to 21 weeks for reporting.

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
872 Total Patients Enrolled
University of Southern CaliforniaOTHER
946 Previous Clinical Trials
1,604,607 Total Patients Enrolled
USFetusLead Sponsor
1 Previous Clinical Trials
110 Total Patients Enrolled
Ruben Quintero, MDPrincipal InvestigatorWellington Regional Medical Center
2 Previous Clinical Trials
247 Total Patients Enrolled
Ramen Chmait, MDPrincipal InvestigatorUniversity of Southern California/ Huntington Memorial Hospital
3 Previous Clinical Trials
812 Total Patients Enrolled

Media Library

Fetoscopy (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT03856034 — N/A
Chiari Malformation Research Study Groups: Fetoscopic repair
Chiari Malformation Clinical Trial 2023: Fetoscopy Highlights & Side Effects. Trial Name: NCT03856034 — N/A
Fetoscopy (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03856034 — N/A
~2 spots leftby Dec 2025
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