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Transanastomotic Tube for Proximal Esophageal Atresia With Distal Tracheoesophageal Fistula Repair
NCT03730454 · View on ClinicalTrials.gov ↗
Study 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.
Conditions Studied
Interventions
- DEVICE Transanastomotic Tube (5FR)
- OTHER No Transanastomotic Tube
Study Locations (10)
California
- Children's Hospital Los Angeles — Los Angeles
- Rady Children's Hospital — San Diego
- Benioff Children's Hospital — San Francisco
- Lucile Packard Children's Hospital — Stanford
Arizona
- Phoenix Children's Hospital — Phoenix
Colorado
- Children's Hospital Colorado — Aurora
Oregon
- Doernbecher Children's Hospital — Portland
Texas
- Children's Medical Center — Dallas
Utah
- Primary Children's Hospital — Salt Lake City
Washington
- Seattle Children's Hospital — Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 142 participants |
| Start Date | 2018-05-11 |
| Est. Completion | 2026-02-28 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03730454
The ClinicalTrials.gov registry entry for NCT03730454 describes a study currently listed as active not recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 142 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Phoenix Children's Hospital, which has 8 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Esophageal Atresia appearing as the primary indexed condition, and to 2 interventions — of which Transanastomotic Tube (5FR) is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT03730454 reports 10 study locations spanning 7 distinct geographic areas — top geographies include California, Arizona, Colorado. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT03730454 about?
NCT03730454 is a clinical study titled "Transanastomotic Tube for Proximal Esophageal Atresia With Distal Tracheoesophageal Fistula Repair". 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 wi...
What is the current status of trial NCT03730454?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 142 participants. The study started on 2018-05-11. Estimated completion is 2026-02-28.
What conditions does trial NCT03730454 study?
This clinical trial studies the following conditions: Esophageal Atresia, Tracheoesophageal Fistula. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT03730454?
The interventions under investigation include: Transanastomotic Tube (5FR) (DEVICE), No Transanastomotic Tube (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03730454?
This trial is sponsored by Phoenix Children's Hospital, which has 8 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT03730454 being conducted?
This trial has 10 study locations across Arizona, California, Colorado, Oregon, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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