Therapeutic Endpoint in Pediatric IBD Conditions
Recruiting · NCT06065228 · Observational (researchers observe without assigning treatment) · Lead sponsor: Children's National Research Institute
View the official record on ClinicalTrials.gov →Interventions studied
AlgometRx Nociometer
What this trial is about
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 can take part
Age range
6 Years to 21 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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.
Where it is running
2 locations listed across 1 US state.
- Children's National Health System - Washington D.C., District of Columbia, United States
- Children's National Health System - Washington D.C., District of Columbia, United States