Phase 2 Study of Esophageal String Test in Diagnosing Eosinophilic Esophagitis

Status: Recruiting
Location: See all (6) locations...
Study Type: Observational
SUMMARY

The overall goal of this study is to develop a novel minimally invasive device, the Esophageal String Test (EST) to monitor esophageal inflammation during treatment of the rare disease Eosinophilic Esophagitis (EoE) in a safe and efficacious manner. This study is broken down into 2 specific aims: Specific Aim 1: Identify the EoE Biomarker Panel (EBP) that will improve the sensitivity and specificity of the EST for documenting esophageal inflammation in a 1-hour time point. Specific Aim 2: Validate the ability of the EST EBP to monitor therapeutic efficacy in a 1-hour sampling time. Funding Source - FDA OOPD

Eligibility
Participation Requirements
Sex: All
Minimum Age: 7
Maximum Age: 65
Healthy Volunteers: Accepts Healthy Volunteers
View:

• Patients undergoing esophagogastroduodenoscopy (EGD) at Children's Hospital Colorado, or

• Patients from a participating site in whom an inflammatory GI disease is suspected.

• Patients with symptoms of:

• abdominal pain,

• vomiting,

• growth delay, or

• malabsorption for which an etiology has not been determined.

• Patients with chronic eosinophilic esophagitis (EoE) in whom symptoms suggest ongoing inflammation.

Locations
United States
Colorado
Children's Hospital Colorado
Recruiting
Aurora
University of Colorado Hospital
Recruiting
Aurora
Illinois
Lurie Children's Hospital
Recruiting
Chicago
Northwestern University
Recruiting
Chicago
OSF St Francis Medical Center
Recruiting
Peoria
Indiana
Indiana University
Completed
Indianapolis
Contact Information
Primary
Kendra Kocher
kendra.kocher@childrenscolorado.org
720-777-5304
Backup
Faria Ahmed
faria.ahmed@childrenscolorado.org
720-777-2797
Time Frame
Start Date: January 2009
Estimated Completion Date: June 2023
Participants
Target number of participants: 440
Treatments
EoE active disease
Inflammation as defined by >15 eos / HPF
EoE remission
No inflammation in EoE patients after treatment
normal control
No inflammation
Sponsors
Leads: University of Colorado, Denver
Collaborators: Northwestern University, OSF Healthcare System, University of Illinois at Chicago

This content was sourced from clinicaltrials.gov

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