10 Participants Needed

Fetoscopic Repair for Gastroschisis

SK
BJ
Overseen ByBecky Johnson
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 1 JurisdictionThis treatment is already approved in other countries

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?

Research suggests that fetoscopic repair for complex gastroschisis may be safe when performed in expert fetal centers, as recent advances in prenatal diagnosis and fetoscopic surgery have improved maternal and fetal safety.12345

How is the fetoscopic repair treatment for gastroschisis different from other treatments?

Fetoscopic repair for gastroschisis is unique because it involves a minimally invasive surgical approach performed before birth to reposition the bowel and close the abdominal defect, potentially preventing bowel damage and complications that occur with traditional postnatal treatments.16789

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?

SK

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

My family and I have decided against ending the pregnancy before 24 weeks or standard treatment after birth.
Parental/guardian permission (informed consent) for follow up of the child after birth
Intraabdominal bowel dilation ≥ 10 mm at 20-24 weeks GA reviewed by prenatal ultrasound
See 7 more

Exclusion Criteria

Maternal-fetal Rh alloimmunization, Kell sensitization, or neonatal alloimmune thrombocytopenia affecting the current pregnancy
Patient does not have a support person (i.e., spouse, partner, or mother) available to support her for the duration of the pregnancy
Placental abnormalities (previa, abruption, accreta) known at time of enrollment
See 13 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Fetoscopic Surgical Repair

Participants undergo minimally invasive in-utero repair of complex gastroschisis via a fetoscopic surgical approach

Surgical procedure
1 visit (in-person)

Post-Surgery Monitoring

Participants are closely followed with ultrasound and consultation after the surgery

Until delivery
Multiple visits (in-person)

Follow-up

Infants are monitored for safety and effectiveness after birth, including neuro-developmental outcomes and survival

12 months
Regular follow-ups (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • Fetal Repair of Complex Gastroschisis
Trial Overview The study is testing the safety and feasibility of repairing complex gastroschisis in unborn babies using fetoscopy—a surgical procedure performed on the fetus. The aim is to see if this can reduce death and complications after birth.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: fetoscopic surgical repairExperimental Treatment1 Intervention
Single arm study. All patients will receive the fetoscopic repair.

Fetal Repair of Complex Gastroschisis is already approved in United States for the following indications:

🇺🇸
Approved in United States as Fetal Repair of Complex Gastroschisis for:
  • Complex Gastroschisis

Find a Clinic Near You

Who Is Running the Clinical Trial?

Baylor College of Medicine

Lead Sponsor

Trials
1,044
Recruited
6,031,000+

Published Research Related to This Trial

Gastroschisis (GS) is a congenital defect where the bowel protrudes from the abdomen, and its severity can range from simple to complex, with complex cases leading to higher risks of complications and mortality.
Recent advances in prenatal diagnosis and fetoscopic surgery suggest that early intervention, such as fetoscopic repair of complex GS, could potentially prevent bowel damage and improve outcomes, warranting further research and reconsideration of current treatment approaches.
Complex gastroschisis: a new indication for fetal surgery?Joyeux, L., Belfort, MA., De Coppi, P., et al.[2021]
In a study involving 21 lamb fetuses with surgically induced gastroschisis, amnioinfusion (saline exchange) significantly improved bowel health, as indicated by increased thickness of bowel muscularis and reduced fibrosis compared to non-infused fetuses.
The results suggest that amnioinfusion may disrupt the inflammatory response associated with gastroschisis, supporting its potential as a therapeutic approach for improving outcomes in affected human fetuses.
Influence of amnioinfusion in a model of in utero created gastroschisis in the pregnant ewe.Luton, D., de Lagausie, P., Guibourdenche, J., et al.[2017]
Complex gastroschisis, characterized by intestinal complications like atresia and necrosis, is the primary factor affecting outcomes and contributes significantly to mortality and morbidity in high-resource settings.
The article aims to clarify the definition of complex gastroschisis and discusses various surgical approaches and their timing, highlighting the need for consensus in treatment strategies.
Surgical strategies in complex gastroschisis.Emil, S.[2018]

Citations

Complex gastroschisis: a new indication for fetal surgery? [2021]
Influence of amnioinfusion in a model of in utero created gastroschisis in the pregnant ewe. [2017]
Surgical strategies in complex gastroschisis. [2018]
Complex gastroschisis is a different entity to simple gastroschisis affecting morbidity and mortality-a systematic review and meta-analysis. [2018]
[Gastroschisis: Prenatal ultrasonography and obstetrical criteria for predicting neonatal outcome]. [2017]
A randomised controlled trial of amnioexchange for fetal gastroschisis. [2022]
Prenatal management of gastroschisis: the place of the amnioexchange procedure. [2019]
Fetoscopic management of gastroschisis in a lamb model. [2021]
Fetal Surgery for Gastroschisis-A Review with Emphasis on Minimally Invasive Procedures. [2022]
Fetoscopic techniques for prenatal covering of gastroschisis in an ovine model are technically demanding and do not lead to permanent anchoring on the fetus until the end of gestation. [2021]
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