Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT03730454 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

Transanastomotic Tube for Proximal Esophageal Atresia With Distal Tracheoesophageal Fistula Repair

Study acronym: TEF
StatusActive, Not Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Trial status: Recruiting to Active, Not Recruitingv6 Show 4 more changesShow less
    • Enrollment target: estimated 150 to confirmed 142
    • Primary completion date changed from estimate of Feb 14, 2025 to Feb 28, 2025
    • Study completion date: Feb 14, 2025 to Feb 28, 2026
    • Site details revised at 10 of 10 sites
  2. Enrollment target: 136 to 150
    • Site contacts updated at 4 of 10 sites
    • Study description expanded, about 5 words
    v5
  3. Study sites: 9 to 10v4
  4. Primary and study completion dates: Feb 14, 2022 to Feb 14, 2025
    • Enrollment target: 150 to 136
    • Site contacts updated at 1 of 9 sites
    v3
  5. Phase: Phase 4 to Not applicable
    • Primary and study completion dates: May 2020 to Feb 14, 2022
    • Secondary endpoints: details revised at 5 of 6 entries
    • Site details revised at 9 of 9 sites
    v2
  6. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT03730454
Lead Sponsor Phoenix Children's Hospital
Conditions
(from sponsor)		 Esophageal Atresia, Tracheoesophageal Fistula
Related terms Esophageal Atresia, Tracheoesophageal Fistula
Enrollment 142 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov