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Therapeutic Endpoint in Pediatric IBD Conditions

NCT06065228 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 60

Last updated 2026-04-08

No results posted yet for this study

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.

Conditions

  • Inflammatory Bowel Diseases
  • Colitis, Ulcerative
  • Crohn Disease

Interventions

DEVICE

AlgometRx Nociometer

Physiologic characterization of disease activity

Sponsors & Collaborators

  • Children's National Research Institute

    lead OTHER

Eligibility

Min Age
6 Years
Max Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-27
Primary Completion
2026-12-31
Completion
2027-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06065228 on ClinicalTrials.gov