Endoscopy Clinical Trials

Clinical trials related to Endoscopy Procedure

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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Maximum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
United States
Massachusetts
Boston Children's Hospital
RECRUITING
Boston
Pennsylvania
Children's Hospital of Philadelphia
RECRUITING
Philadelphia
Contact Information
Primary
Jessica Yasuda, MD
Jessica.Yasuda@childrens.harvard.edu
617-355-3038
Backup
James Orozco, DO
james.orozco@childrens.harvard.edu
Time Frame
Start Date: 2025-10-28
Estimated Completion Date: 2028-06-24
Participants
Target number of participants: 128
Treatments
Experimental: Group A (30 seconds)
Patients who are randomized into Group A will undergo endoscopic balloon dilation for a total of 30 seconds.
Experimental: Group B (180 seconds)
Patients randomized into Group B will undergo endoscopic balloon dilation for a duration of 180 seconds.
Sponsors
Collaborators: Children's Hospital of Philadelphia
Leads: Boston Children's Hospital

This content was sourced from clinicaltrials.gov

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