Therapeutic Endpoint in Pediatric IBD Conditions

Part of paid clinical trials in Washington D.C., District of Columbia.

Sponsor
Children's National Research Institute
Study ID
NCT06065228
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
6 Years - 21 Years
Healthy Volunteers
Not accepted

Interventions

  • AlgometRx Nociometer — DEVICE
    Physiologic characterization of disease activity

Study Details

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.

Key Dates

Start date
Nov 27, 2023
Status verified
Apr 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2027

Study Design

Enrollment
60 participants (estimated)

Arms

  • Arm: UC
  • Arm: CD

Primary Outcome Measure

The primary objective of this study is the measurement of the nociceptive index for clinical output. [ Time Frame: 1 Year ]

Locations (1)

FacilityCityStateZIPSite coordinators
Children's National Health SystemWashington D.C.District of Columbia20010
Julia C Finkel, MD
[email protected]
(888) 884-2327
Julia C Finkel, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Washington D.C., DC

By condition
Crohn's disease
By specialty
GastroenterologyInflammatory bowel diseaseAutoimmune disease
By research site
Children's National Health System· Washington D.C., DC

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