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NCT05704257 · ClinicalTrials.gov registry record · NA
Fetal Repair of Complex Gastroschisis: A Safety and Feasibility Trial
A NA study of Gastroschisis, sponsored by Baylor College of Medicine.
- Recruiting
- Registry status
- NA
- Development phase
- 10
- Enrollment target
- 1
- Study location
NCT05704257: Recruiting NA study of Gastroschisis, sponsored by Baylor College of Medicine.
NCT05704257 is a NA study of Gastroschisis that is actively recruiting participants, run by Baylor College of Medicine. The registered enrollment target is 10 participants, below the 94-participant average among 4 other Gastroschisis trials with a reported enrollment target (89% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05704257, a NA study of Gastroschisis, is actively recruiting participants, sponsored by Baylor College of Medicine.
- RECRUITING
- Registry status
- NA
- Development phase
- 10 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
Success of primary skin closure after complete bowel reduction.
Conditions Studied
Interventions
- DEVICE fetoscopy
Study Locations (1)
Texas
- Texas Children's Hospital - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2023-10-20 |
| Est. Completion | 2029-12 |
| Phase | NA |
What NCT05704257 shows while recruiting
NCT05704257 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 94-participant average among 4 other Gastroschisis trials with a reported enrollment target (89% lower).
The record links to 1 condition, with Gastroschisis appearing as the primary indexed condition, and to 1 intervention - of which fetoscopy is the first listed.
NCT05704257 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT05704257 about?
NCT05704257 is a clinical study titled "Fetal Repair of Complex Gastroschisis: A Safety and Feasibility Trial". 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 ...
What is the current status of trial NCT05704257?
This trial is currently recruiting. It is a NA study. The enrollment target is 10 participants. The study started on 2023-10-20. Estimated completion is 2029-12.
What conditions does trial NCT05704257 study?
This clinical trial studies the following conditions: Gastroschisis.
What interventions are being tested in trial NCT05704257?
The interventions under investigation include: fetoscopy (DEVICE).
Who is sponsoring clinical trial NCT05704257?
This trial is sponsored by Baylor College of Medicine, which has 616 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05704257 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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