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Transanastomotic Tube for Esophageal Atresia (TEF Trial)

N/A
Recruiting
Led By Justin Lee, MD
Research Sponsored by Phoenix Children's Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Infants diagnosed with type C esophageal atresia: proximal esophageal atresia and distal tracheoesophageal fistula
Primary repair of the esophageal atresia within the first six months of life
Must not have
Major anomaly that influences likelihood of developing primary outcome or affects surgical treatment considerations
Other types of esophageal atresia without esophageal anastomosis creation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
No Placebo-Only Group

Summary

This trial is comparing two surgical practices for repairing Type C esophageal atresia. The primary outcome is the development of an anastomotic stricture requiring dilation within 12 months.

Who is the study for?
This trial is for infants needing surgery for Type C esophageal atresia, which is a birth defect affecting the tube that connects the mouth to the stomach. Infants must be under six months old and able to have follow-ups for at least one year.
What is being tested?
The study compares two surgical methods for repairing esophageal atresia with tracheoesophageal fistula in infants: one using a transanastomotic tube during surgery, and one without it. The main focus is on whether an uncomfortable narrowing of the connection (stricture) develops within a year.
What are the potential side effects?
Potential side effects are not specified but may include typical risks associated with pediatric surgery such as infection, reaction to anesthesia, or complications related to the presence or absence of the transanastomotic tube.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My infant has a specific type of esophageal birth defect.
Select...
My esophageal atresia was surgically repaired within my first six months.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have a major health issue that could affect my treatment outcome.
Select...
My condition involves a type of esophageal atresia without surgery to connect the esophagus.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Anastomotic stricture
Secondary study objectives
Anastomotic Leak
Duration of perenteral nutrition
Length of Stay
+3 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Group B. No Transanastomotic TubeExperimental Treatment1 Intervention
Group B. No Transanastomotic tube group: Standard repair of EA/TEF will be performed. TT will NOT be used during the esophageal anastomosis creation.
Group II: Group A. Transanastomotic TubeExperimental Treatment1 Intervention
Group A. Transanastomotic Tube: Standard repair of EA/TEF will be performed. TT will be used during the esophageal anastomosis creation.

Find a Location

Who is running the clinical trial?

Phoenix Children's HospitalLead Sponsor
76 Previous Clinical Trials
5,013,642 Total Patients Enrolled
Justin Lee, MDPrincipal InvestigatorPhoenix Children's Hospital
2 Previous Clinical Trials
200 Total Patients Enrolled

Media Library

No Transanastomotic Tube Clinical Trial Eligibility Overview. Trial Name: NCT03730454 — N/A
Esophageal Atresia Research Study Groups: Group A. Transanastomotic Tube, Group B. No Transanastomotic Tube
Esophageal Atresia Clinical Trial 2023: No Transanastomotic Tube Highlights & Side Effects. Trial Name: NCT03730454 — N/A
No Transanastomotic Tube 2023 Treatment Timeline for Medical Study. Trial Name: NCT03730454 — N/A
~2 spots leftby Feb 2025
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