Fetal Repair of Complex Gastroschisis: A Safety and Feasibility Trial

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The goal of this clinical trial is to evaluate the safety and feasibility of fetal repair of complex gastroschisis (GS) via a fetoscopic surgical approach by assessing maternal, fetal, neonatal, and infant outcomes in a cohort of 10 patients. The hypothesis is that in utero repair of GS will reduce postnatal mortality and morbidity in complex GS infants with minimal maternal and fetal risk.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
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• Pregnant women - maternal age 18 years or older and capable of consenting for her own participation in this study

• Singleton pregnancy

• Sonographic evidence of gastroschisis (exteriorization of bowel content outside the fetal abdominal cavity into the amniotic cavity)

• Intraabdominal bowel dilation ≥ 8 mm at 20-24 weeks GA reviewed by prenatal ultrasound

• Absence of significant associated anomalies\* diagnosed on prenatal ultrasound or MRI

• Gestational age at the time of the procedure will be between 20 0/7 weeks and 25 6/7 weeks

• Absence of chromosomal and clinically significant abnormalities, i.e., normal karyotype and/or normal chromosomal microarray (CMA) by invasive testing (amniocentesis or Chorionic Villus Sampling (CVS)). If there is a balanced translocation with normal CMA with no other anomalies the candidate can be included. Results by fluorescence in situ hybridization (FISH) will be accepted, if the candidate's gestation age is ≥ 22 0/7 weeks. Patients declining invasive testing will be excluded

• The family has considered and declined the option of termination of the pregnancy at less than 24 weeks and of standard postnatal treatment

• The family meets psychosocial criteria (sufficient social support, ability to understand the requirements of the study)

⁃ Parental/guardian permission (informed consent) for follow up of the child after birth

‣ Significant associated anomalies are defined as such anomalies that would, in and of themselves, be life limiting or life threatening. A minor anomaly, such as a small VSD or ASD not deemed to be life limiting or threatening, or a cleft lip or other such anomaly, unless part of a genetic syndrome, will not disqualify the patient.

Locations
United States
Texas
Texas Children's Hospital
RECRUITING
Houston
Contact Information
Primary
Sundeep Keswani, MD
sgkeswan@texaschildrens.org
832-824-0462
Backup
Becky Johnson
rj2@bcm.edu
832-826-7451
Time Frame
Start Date: 2023-10-20
Estimated Completion Date: 2029-12
Participants
Target number of participants: 10
Treatments
Experimental: fetoscopic surgical repair
Single arm study. All patients will receive the fetoscopic repair.
Related Therapeutic Areas
Sponsors
Leads: Baylor College of Medicine

This content was sourced from clinicaltrials.gov