Therapeutic Endpoint in Pediatric IBD Conditions | NCT06065228

Studies
Therapeutic Endpoint in Pediatric IBD Conditions

NCT06065228

Sponsor

Children's National Research Institute

Status

Recruiting

Last Update Posted

Apr 8, 2026Actual

Enrollment

60Estimated

Phase

Not provided

Conditions

Inflammatory Bowel Diseases
Colitis, Ulcerative
Crohn Disease

Interventions

AlgometRx Nociometer

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 27, 2023Actual

Primary Completion Date

Dec 2026Estimated

Completion Date

Dec 2027Estimated

First Submitted Date

Sep 27, 2023

First Submission Date that Met QC Criteria

Sep 27, 2023

First Posted Date

Oct 3, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 3, 2026

Last Update Posted Date

Apr 8, 2026Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Julia Finkel, Professor of Anesthesiology and Pediatrics, Children's National Research InstitutePrincipal Investigator

Lead Sponsor

Children's National Research InstituteOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Yes

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
UC			Device: AlgometRx Nociometer
CD			Device: AlgometRx Nociometer

Interventions

Name	Type	Description	Arm Group Labels	Other Names
AlgometRx Nociometer	Device	Physiologic characterization of disease activity	CD UC

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The primary objective of this study is the measurement of the nociceptive index for clinical output.		1 Year

Secondary Outcomes

Measure	Description	Time Frame
The secondary objective of this study is the characterization of the nociceptive index in IBD populations in response to standard of care interventions.		1 Year

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Years

Maximum Age

21 Years

Standard Ages

ChildAdult

Study Population

This study proposes to enroll patients diagnosed with IBD in a longitudinal design.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Children's National Health System	Recruiting	Washington D.C.	District of Columbia	20010	United States

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D015212	Inflammatory Bowel Diseases
D003093	Colitis, Ulcerative
D003424	Crohn Disease

Ancestor Terms

ID	Term
D005759	Gastroenteritis
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases
D007410	Intestinal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided