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Not Yet RecruitingNANCT07100379

Balloon Inflation Time for Esophageal Strictures (BITES): A Randomized Multi-Center 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, w...

Lead sponsor: Boston Children's Hospital•View source on ClinicalTrials.gov

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Contacts

Jessica Yasuda, MD

CONTACT

617-355-3038 Jessica.Yasuda@childrens.harvard.edu

Sponsors

Lead Sponsor

Boston Children's Hospital

Age

0 - 18 years

Sex

ALL

Healthy Volunteers

No

Inclusion Criteria

•Diagnosed with esophageal atresia with and without tracheoesophageal fistula, surgically repaired esophageal atresia, esophageal anastomotic strictures requiring endoscopic balloon dilation, and at least 1 endoscopic balloon dilation for esophageal anastomotic strictures within a 6 month period.

Exclusion Criteria

•Patients who need endoscopic incisional therapy to manage anastomotic stricture during their first follow up endoscopy, patients requiring administration of intralesional steroid within 4 weeks of repair, have no follow up endoscopy within 6 months period, have any anastomosis type other than esophago-esophageal (e.g. jejunal or colonic interposition), and/or failure to meet target dilation time.

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: August 3, 2025Terms

Trial snapshot

StatusNOT_YET_RECRUITING

PhaseNA

Enrollment128

Start dateSep 2025

Last updatedAug 3, 2025

Condition

Esophageal Atresia With Tracheo-esophageal Fistula Esophageal Atresia Esophageal Strictures

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 3, 2025Data synced to Clareo: May 3, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions