Fetal Repair of Complex Gastroschisis: A Safety and Feasibility Trial

Part of paid clinical trials in Houston, Texas.

Sponsor
Baylor College of Medicine
Study ID
NCT05704257
Status
Recruiting
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Conditions

  • Gastroschisis

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • fetoscopy — DEVICE
    The fetoscopic arm is described above. All patients will have a laparotomy, exteriorization of the uterus, and a fetoscopic repair of the gastroschisis.

Study Details

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.

Key Dates

Start date
Oct 20, 2023
Status verified
Apr 2026
Primary completion
Dec 31, 2029
Completion
Dec 31, 2029

Study Design

Enrollment
10 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY

Arms

  • Experimental: fetoscopic surgical repair
    Single arm study. All patients will receive the fetoscopic repair.

Primary Outcome Measure

Successful Repair of Complex Gastroschisis [ Time Frame: At end of surgical repair ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Texas Children's HospitalHoustonTexas77030
Sundeep Keswani, MD
Becky Johnson
[email protected]
832-826-7451
Sundeep Keswani, MD (PRINCIPAL_INVESTIGATOR)
Michael A Belfort, MD, PhD (SUB_INVESTIGATOR)
Luc Joyeux, MD, PhD (SUB_INVESTIGATOR)
Larry Hollier Jr., MD (SUB_INVESTIGATOR)
Timothy Lee, MD (SUB_INVESTIGATOR)
Alice King, MD (SUB_INVESTIGATOR)
Magdalena Sanz Cortes, MD, PhD (SUB_INVESTIGATOR)
Ahmed Nassr, MD, PhD (SUB_INVESTIGATOR)
Roopali Donepudi, MD (SUB_INVESTIGATOR)
Jonathan Castillo Porter, MD, MPH (SUB_INVESTIGATOR)
Caitlin Sutton, MD (SUB_INVESTIGATOR)
Becky Johnson, MS, CCRP (SUB_INVESTIGATOR)

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By research site
Texas Children's Hospital· Houston, TX

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