RecruitingNot ApplicableNCT05704257

Fetal Repair of Complex Gastroschisis: A Safety and Feasibility Trial

Sponsor

Baylor College of Medicine

Enrollment

10 participants

Start Date

Oct 20, 2023

Study Type

INTERVENTIONAL

Conditions

gastroschisis

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

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called fetoscopy for people with gastroschisis. The study is currently recruiting participants at 1 location. People eligible for this study include women aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEfetoscopy

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