NCT07100379 Balloon Inflation Time for Esophageal Strictures (BITES): A Randomized Multi-Center Study
| NCT ID | NCT07100379 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Boston Children's Hospital |
| Condition | Esophageal Atresia With Tracheo-esophageal Fistula |
| Study Type | INTERVENTIONAL |
| Enrollment | 128 participants |
| Start Date | 2025-10-28 |
| Primary Completion | 2027-06-24 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 128 participants in total. It began in 2025-10-28 with a primary completion date of 2027-06-24.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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.
Contact & Investigator
Jessica Yasuda, MD
PRINCIPAL INVESTIGATOR
Boston Children's Hospital
Frequently Asked Questions
Who can join the NCT07100379 clinical trial?
This trial is open to participants of all sexes, up to 18 Years, studying Esophageal Atresia With Tracheo-esophageal Fistula. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07100379 currently recruiting?
Yes, NCT07100379 is actively recruiting participants. Contact the research team at Jessica.Yasuda@childrens.harvard.edu for enrollment information.
Where is the NCT07100379 trial being conducted?
This trial is being conducted at Boston, United States, Philadelphia, United States.
Who is sponsoring the NCT07100379 clinical trial?
NCT07100379 is sponsored by Boston Children's Hospital. The principal investigator is Jessica Yasuda, MD at Boston Children's Hospital. The trial plans to enroll 128 participants.