Clinical Trial

Transanastomotic Tube for Proximal Esophageal Atresia With Distal Tracheoesophageal Fistula Repair

Study acronym: TEF
Active, Not Recruiting
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Summary
This trial will compare the effectiveness of two common surgical practices for Type C esophageal atresia repair: esophageal atresia (EA) with distal tracheoesophageal fistula (TEF). Infants with EA/TEF requiring surgical intervention will be recruited. Subjects will be randomized to either repair with or without transanstomotic tube (TT) during esophageal anastomosis creation. Primary outcome is symptomatic anastomotic stricture development requiring dilation within 12 months.
Protocol Amendment History 5 amendments
This ClinicalTrials.gov record has been amended 5 times since 2018-11-01; most recent amendment 2025-03-05.
Status change: Recruiting → Active, Not Recruiting 2025-03-05
Trial Details
NCT Number NCT03730454
Lead Sponsor Phoenix Children's Hospital
Conditions Esophageal Atresia, Tracheoesophageal Fistula
Enrollment 142 participants
Start Date 2018-05-11
Primary Completion 2025-02-28 (estimated)
Study Completion 2026-02-28 (estimated)
Updated on ClinicalTrials.gov 2025-03-10