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NCT07100379: BITES
Balloon Inflation Time for Esophageal Strictures (BITES): A Randomized Multi-Center Study
NA trial testing Endoscopic Balloon Dilation in Esophageal Atresia With Tracheo-esophageal Fistula in 128 participants. Not yet recruiting.
24 June 2027
Quick facts
| Lead sponsor | Boston Children's Hospital |
|---|---|
| Phase | NA |
| Status | Not yet recruiting |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 128 |
| Start date | 1 September 2025 |
| Primary completion | 24 June 2027 |
| Estimated completion | 24 June 2027 |
Drugs / interventions tested
- Endoscopic Balloon Dilation
Conditions studied
- Esophageal Atresia With Tracheo-esophageal Fistula — all drugs for Esophageal Atresia With Tracheo-esophageal Fistula →
- Esophageal Atresia — all drugs for Esophageal Atresia →
- Esophageal Strictures — all drugs for Esophageal Strictures →
Sponsor
Boston Children's Hospital
Who can join
Under 18, any sex, with Esophageal Atresia With Tracheo-esophageal Fistula or Esophageal Atresia. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT07100379
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07100379 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Boston Children's Hospital
- Last refreshed: 3 August 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07100379.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing