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Study identifier: NCT07100379 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

Balloon Inflation Time for Esophageal Strictures (BITES): A Randomized Multi-Center Study

Condition: Esophageal Atresia With Tracheo-esophageal Fistula · Esophageal Atresia · Esophageal Strictures  ·  Sponsor: Boston Children's Hospital

PhaseNA
Planned participants128
Who can joinAll sexes, N/A to 18 Years
Healthy volunteersNo

About this study

Esophageal atresia (EA) is one of the most common gastrointestinal congenital anomalies that affects 1 in 2500 to 1 in 4000 live births. It is characterized by abnormal development of the esophagus, which requires surgical intervention to be compatible with life. Surgical repair of EA is associated with risk of developing esophageal strictures or narrowing, which nearly affects 40% of cases. Strictures can be treated using endoscopic balloon dilation, which consists of introducing a catheter with a balloon into the esophagus via endoscopy and positioning it across stricture followed by balloon inflation. The inflated balloon is held in position for a set amount of time with the goal to dilate the narrowed area. At this time there are no pediatric studies comparing difference balloon dilation times and outcomes. Our study's goal is to evaluate balloon dilation inflation time in treating esophageal anastomotic strictures to understand if inflation time is associated with outcome.

This description comes directly from the study's public registry record.

Talk to the study team

Jessica Yasuda, MD  ·  617-355-3038  ·  Jessica.Yasuda@childrens.harvard.edu

James Orozco, DO  ·  james.orozco@childrens.harvard.edu

Always discuss trial participation with your own doctor first.

Locations (2)

Boston Children's HospitalBoston, Massachusetts, United StatesRecruiting
Children's Hospital of PhiladelphiaPhiladelphia, Pennsylvania, United StatesRecruiting

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Source record: clinicaltrials.gov/study/NCT07100379