Fetoscopic Repair for Gastroschisis
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to test a new surgery for unborn babies with severe bowel issues where their intestines are outside their belly. The surgery is done through a small opening in the mother's womb using a camera and tiny tools. This method hopes to reduce complications after birth compared to traditional treatments.
Do I need to stop my current medications for the trial?
The trial protocol does not specify whether you need to stop taking your current medications. It's best to discuss your specific medications with the trial team to get a clear answer.
Is fetoscopic repair for gastroschisis safe for humans?
How is the fetoscopic repair treatment for gastroschisis different from other treatments?
What data supports the effectiveness of the treatment Fetoscopic Repair for Gastroschisis?
Research suggests that fetoscopic surgery, which involves minimally invasive techniques to repair the condition before birth, may help reduce bowel damage and complications in complex gastroschisis. Advances in prenatal diagnosis and fetoscopic techniques have shown potential benefits, although more research is needed to confirm these findings.134810
Who Is on the Research Team?
Sundeep Keswani, MD
Principal Investigator
Baylor College of Medicine and Texas Children's Hospital
Are You a Good Fit for This Trial?
This trial is for pregnant women over 18 with a single pregnancy between 20-25 weeks, where the fetus has gastroschisis. Candidates must have normal genetic tests and no significant unrelated anomalies or maternal health issues that could complicate surgery.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Fetoscopic Surgical Repair
Participants undergo minimally invasive in-utero repair of complex gastroschisis via a fetoscopic surgical approach
Post-Surgery Monitoring
Participants are closely followed with ultrasound and consultation after the surgery
Follow-up
Infants are monitored for safety and effectiveness after birth, including neuro-developmental outcomes and survival
What Are the Treatments Tested in This Trial?
Interventions
- Fetal Repair of Complex Gastroschisis
Fetal Repair of Complex Gastroschisis is already approved in United States for the following indications:
- Complex Gastroschisis
Find a Clinic Near You
Who Is Running the Clinical Trial?
Baylor College of Medicine
Lead Sponsor