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Clinical Trials/EUCTR2018-002863-24-DK
EUCTR2018-002863-24-DK
Active, not recruiting
Phase 1

Intralesional steroid injections to prevent refractory strictures in patinets with esophageal atresia - a randomized controlled trial

Erasmus MC0 sites110 target enrollmentJune 23, 2021
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ConditionsRecurrent stenosis after correction of esophageal atresiaMedDRA version: 20.0Level: LLTClassification code 10045322Term: Ulcer of eosophagusSystem Organ Class: 100000004856Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
DrugsKenacort A-10

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Recurrent stenosis after correction of esophageal atresia
Sponsor
Erasmus MC
Enrollment
110
Status
Active, not recruiting
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
June 23, 2021
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
Erasmus MC

Eligibility Criteria

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

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

Outcomes

Primary Outcomes

Not specified

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