Therapeutic Endpoint in Pediatric IBD Conditions
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: AlgometRx Nociometer.
- Who it may be relevant to
- Registry conditions: Inflammatory Bowel Diseases, Colitis, Ulcerative, Crohn Disease. Basic parameters: 6 years — 21 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Development of a Therapeutic Endpoint in Pediatric IBD Conditions
Overview
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.
Interventions
- Device AlgometRx Nociometer
Physiologic characterization of disease activity
Primary outcome measures
- The primary objective of this study is the measurement of the nociceptive index for clinical output. [Time frame: 1 Year]
Secondary outcome measures (1)
- The secondary objective of this study is the characterization of the nociceptive index in IBD populations in response to standard of care interventions. [Time frame: 1 Year]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- Children's National Health System — Washington D.C.
Identifiers
NCT: NCT06065228 · STUDY00000658