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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

TEF Trial 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.Check my eligibility

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.See study design

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.

TEF Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My infant has a specific type of esophageal birth defect.

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My esophageal atresia was surgically repaired within my first six months.

TEF Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Anastomotic stricture

Secondary outcome measures

Anastomotic Leak

Duration of perenteral nutrition

Length of Stay

+3 more

TEF 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.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Phoenix Children's HospitalLead Sponsor

74 Previous Clinical Trials

5,013,865 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Where are the various sites conducting this clinical research?

"At this point in time, 9 sites are actively enlisting participants for the trial. These medical centres can be found in Seattle, San Diego and Stanford; as well as 6 other locations. To reduce travel burden, individuals should choose the clinic which is closest to their home."

Answered by AI

Are there any opportunities presently available to join this research trial?

"Confirmed, the trial is currently recruiting. It was first posted on 11th May 2018 and had its latest update 22nd April 2022."

Answered by AI

How many individuals have signed up to participate in this medical experiment?

"This clinical trial requires 136 participants who meet the set criteria. Potential patients can enrol from Seattle Children's Hospital in Washington or Rady Children's Hospital in California."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Transanastomotic Tube for Proximal Esophageal Atresia With Distal Tracheoesophageal Fistula Repair

Justin Lee, MD 2018. "Transanastomotic Tube for Proximal Esophageal Atresia With Distal Tracheoesophageal Fistula Repair". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03730454.

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