NCT06065228Recruiting
Therapeutic Endpoint in Pediatric IBD Conditions
Children's National Research Institute
Start Date
11/27/2023
Completion Date
12/1/2027
Summary
The purpose of this clinical study is the development of physiologic endpoint of inflammation in pediatric patients diagnosed with inflammatory bowel disease (IBD), specifically subtypes Crohn's disease (CD) and ulcerative colitis (UC). The novel medical device evaluates the patient's sensory response to each of the three sensory nerve fiber types. Data from the device provides an assessment of disease activity and a more precise approach to treatment.
Eligibility Criteria
Age Range: 6 years to 21 years
Inclusion Criteria:
* Male or female ≥ 6 years of age at screening.
* Documentation of an IBD diagnosis as evidenced by history
Exclusion Criteria:
* Documented history of eye disease precluding pupillometry
* Patients who are unwilling or unable to participate due to developmental delays or ongoing psychological diagnoses.
Interventions
DEVICE
AlgometRx Nociometer
Conditions
Inflammatory Bowel DiseasesColitis, UlcerativeCrohn Disease
Locations
Children's National Health System
Washington D.C., District of Columbia 20010
United States