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NCT07100379 · ClinicalTrials.gov registry record · NA
Balloon Inflation Time for Esophageal Strictures (BITES): A Randomized Multi-Center Study
A NA study, sponsored by Boston Children's Hospital.
- Recruiting
- Registry status
- NA
- Development phase
- 128
- Enrollment target
NCT07100379: Recruiting NA study, sponsored by Boston Children's Hospital.
NCT07100379 is a NA study that is actively recruiting participants, run by Boston Children's Hospital. The registered enrollment target is 128 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (91% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07100379, a NA study, is actively recruiting participants, sponsored by Boston Children's Hospital.
- RECRUITING
- Registry status
- NA
- Development phase
- 128 participants
- Enrollment target
Study 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.
Primary Outcome
Study aims to determine whether the efficacy of endoscopic ballon dilation depends on duration of balloon inflation duration and does this influence the need for repeat endoscopic balloon dilations. Response to dilation will be defined by total number of dilations needed to treat stricture in a 6 month period.
Interventions
- PROCEDURE Endoscopic Balloon Dilation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 128 participants |
| Start Date | 2025-10-28 |
| Est. Completion | 2028-06-24 |
| Phase | NA |
What NCT07100379 shows while recruiting
NCT07100379 is an interventional study that assigns participants to a tested intervention. The registered 128 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (91% lower).
The record links to 0 conditions, and to 1 intervention - of which Endoscopic Balloon Dilation is the first listed.
NCT07100379 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07100379 about?
NCT07100379 is a clinical study titled "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, which requires surgical intervention to be compatible with life. Surgical repair of EA is associated ...
What is the current status of trial NCT07100379?
This trial is currently recruiting. It is a NA study. The enrollment target is 128 participants. The study started on 2025-10-28. Estimated completion is 2028-06-24.
What interventions are being tested in trial NCT07100379?
The interventions under investigation include: Endoscopic Balloon Dilation (PROCEDURE).
Who is sponsoring clinical trial NCT07100379?
This trial is sponsored by Boston Children's Hospital, which has 462 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07100379's enrollment target sits among peer trials
128 744th of 2000 higher than 1,252 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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