RECRUITINGOBSERVATIONAL
Therapeutic Endpoint in Pediatric IBD Conditions
Development of a Therapeutic Endpoint in Pediatric IBD Conditions
About This Trial
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.
Who May Be Eligible (Plain English)
Who May Qualify:
- Male or female ≥ 6 years of age at screening.
- Documentation of an IBD diagnosis as evidenced by history
Who Should NOT Join This Trial:
- Documented history of eye disease precluding pupillometry
- Patients who are unwilling or unable to participate due to developmental delays or ongoing psychological diagnoses.
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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.
Treatments Being Tested
OTHER
AlgometRx Nociometer
Physiologic characterization of disease activity
Locations (1)
Children's National Health System
Washington D.C., District of Columbia, United States