Fibrostenotic Eosinophilic Esophagitis: Assessment Tools
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ClinicalTrials.gov Identifier: NCT02453126 |
Recruitment Status :
Recruiting
First Posted : May 25, 2015
Last Update Posted : January 18, 2023
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Condition or disease |
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Eosinophilic Esophagitis |
Study Type : | Observational |
Estimated Enrollment : | 250 participants |
Observational Model: | Case-Control |
Time Perspective: | Prospective |
Official Title: | Fibrostenotic Eosinophilic Esophagitis: Endoscopic, Histologic and Molecular Characterization and Evaluation of Clinical Assessment Tools |
Study Start Date : | December 2014 |
Estimated Primary Completion Date : | June 2024 |
Estimated Study Completion Date : | June 2024 |

- Stricture, as measured by endoscopic assessment [ Time Frame: Day 1 ]
- Decreased esophageal distensibility, as determined by EndoFlip [ Time Frame: Day 1 ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 5 Years to 18 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- Scheduled to undergo a clinical upper endoscopy with biopsy
Exclusion Criteria:
- Known connective tissue disorder
- Increased risk of bleeding
- Inflammatory bowel disease, celiac disease, eosinophilic gastroenteritis, or any autoimmune disease
- Other esophageal disease including known achalasia; history of caustic ingestion, esophageal surgery esophageal stricture for other known reason or other esophageal injury.
- Use of oral or intravenous steroids in the preceding 60 days. (Swallowed topical fluticasone, budesonide, etc not included as exclusion criteria.)

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02453126
Contact: Cassandra Burger | 720-777-5739 | cassandra.burger@childrenscolorado.org |
United States, Colorado | |
Children's Hospital Colorado | Recruiting |
Aurora, Colorado, United States, 80045 | |
Contact: Cassandra Burger 720-777-5739 cassandra.burger@childrenscolorado.org |
Principal Investigator: | Calies Menard-Katcher, MD | University of Colorado/Childrens Hospital Colorado |
Responsible Party: | University of Colorado, Denver |
ClinicalTrials.gov Identifier: | NCT02453126 |
Other Study ID Numbers: |
14-0594 UL1TR001082 ( U.S. NIH Grant/Contract ) |
First Posted: | May 25, 2015 Key Record Dates |
Last Update Posted: | January 18, 2023 |
Last Verified: | January 2023 |
Eosinophilic Esophagitis Esophageal Stricture |
Esophagitis Eosinophilic Esophagitis Esophageal Diseases Gastrointestinal Diseases Digestive System Diseases Gastroenteritis |
Eosinophilia Leukocyte Disorders Hematologic Diseases Hypersensitivity, Immediate Hypersensitivity Immune System Diseases |