In-Utero Surgery Techniques for Spina Bifida
What You Need to Know Before You Apply
What is the purpose of this trial?
The purpose of this study is to evaluate the feasibility and effectiveness of performing fetoscopic surgical correction of fetal spina bifida. Two surgical approaches will be utilized: the percutaneous technique versus the laparotomy/uterine exteriorization technique.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Is in-utero surgery for spina bifida generally safe for humans?
In-utero surgery for spina bifida, especially using the endoscopic approach, is considered feasible and tends to have lower risks for mothers compared to open surgery. However, both open and endoscopic surgeries have similar safety profiles in hospitals, and there are still some maternal and fetal risks involved.12345
How does the in utero endoscopic correction of myelomeningocele treatment differ from other treatments for spina bifida?
What data supports the effectiveness of this treatment for spina bifida?
Who Is on the Research Team?
Ruben Quintero, MD
Principal Investigator
US Fetus
Ramen Chmait, MD
Principal Investigator
University of Southern California
Are You a Good Fit for This Trial?
This trial is for pregnant women over 18 with a fetus diagnosed with spina bifida (T1-S1 level) and hindbrain herniation, between 19-27 weeks' gestation. Candidates must have normal genetic test results, be able to consent and follow the study plan, and have support systems in place. Exclusions include multiple pregnancies, certain maternal health issues like diabetes or obesity (BMI ≥40), previous early deliveries, positive HIV/Hepatitis-B status or other conditions that risk surgery/anesthesia.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Surgery
Fetoscopic surgical correction of fetal spina bifida using either the percutaneous or laparotomy/uterine exteriorization technique
Follow-up
Participants are monitored for safety and effectiveness after the surgical procedure
What Are the Treatments Tested in This Trial?
Interventions
- In Utero Endoscopic Correction of Myelomeningocele IDE - Laparotomy/Uterine Exteriorization Technique
- In Utero Endoscopic Correction of Myelomeningocele IDE - Percutaneous Technique
In Utero Endoscopic Correction of Myelomeningocele IDE - Laparotomy/Uterine Exteriorization Technique is already approved in United States, European Union for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Southern California
Lead Sponsor
USFetus
Collaborator