NCT06065228

Therapeutic Endpoint in Pediatric IBD Conditions

Development of a Therapeutic Endpoint in Pediatric IBD Conditions

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 60 (estimated)
• Sponsor: Children's National Research Institute · Academic / Other
• Sex: All
• Age: 6 Years – 21 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
DEVICE	AlgometRx Nociometer	Physiologic characterization of disease activity

Timeline

• Start date: 2023-11-27
• Primary completion: 2026-12-01
• Completion: 2027-12-01
• First posted: 2023-10-03
• Last updated: 2026-04-08

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study