128 Participants NeededMy employer runs this trial

Endoscopic Balloon Dilation for Esophageal Strictures

(BITES Trial)

Recruiting at 1 trial location
JY
JO
Overseen ByJames Orozco, DO
Age: < 65
Sex: Any
Trial Phase: Academic
Sponsor: Boston Children's Hospital
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

JY

Jessica Yasuda, MD

Principal Investigator

Boston Children's Hospital

Are You a Good Fit for This Trial?

Inclusion Criteria

I had surgery for esophageal atresia and needed a balloon dilation for a stricture.

What Are the Treatments Tested in This Trial?

Interventions

  • Endoscopic Balloon Dilation

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: Group B (180 seconds)Experimental Treatment1 Intervention
Group II: Group A (30 seconds)Experimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Boston Children's Hospital

Lead Sponsor

Trials
801
Recruited
5,584,000+

Children's Hospital of Philadelphia

Collaborator

Trials
749
Recruited
11,400,000+