Prevention of recurrent narrowing of the esophagus after correction of esophageal atresia by injecting steroids

Phase 1

• Conditions: Recurrent stenosis after correction of esophageal atresia; MedDRA version: 20.0Level: LLTClassification code 10045322Term: Ulcer of eosophagusSystem Organ Class: 100000004856; Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]

• Registration Number: EUCTR2018-002863-24-DK
• Lead Sponsor: Erasmus MC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-06-23
• Last Update Posted: 26 February 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 110

Inclusion Criteria

The following patients are eligible for the study:
-Children with EA type C who underwent primary anastomotic surgery within the first days of life
-Age =3 months at the time of the 3rd dilatation
-In need of a 3rd dilatation
-Written informed consent by both parents or legal representatives, if applicable
Are the trial subjects under 18? yes
Number of subjects for this age range: 110
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range 0
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

The following patients are excluded from the study:
-Age <3 months
-Known inability from previous dilatations to use an endoscope with a size of 5.8 mm
-No parental written informed consent

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified