Use of Thermal and 3D Imaging to Quantify Arthritis | NCT01044823

Studies
Use of Thermal and 3D Imaging to Quantify Arthritis

NCT01044823

Sponsor

University of Pittsburgh

Status

Completed

Last Update Posted

Jul 31, 2017Actual

Enrollment

157Actual

Phase

Not provided

Conditions

Rheumatoid Arthritis
Juvenile Rheumatoid Arthritis

Interventions

3D and thermal imaging

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

ID	Type	Description	Link
R21AR056690	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Feb 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2010

Primary Completion Date

Mar 2011Actual

Completion Date

Jan 2014Actual

First Submitted Date

Jan 6, 2010

First Submission Date that Met QC Criteria

Jan 7, 2010

First Posted Date

Jan 8, 2010Estimated

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

Jul 26, 2017

Last Update Posted Date

Jul 31, 2017Actual

Name	Class
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

One of the biggest challenges in caring for patients with Rheumatoid Arthritis (RA) and Juvenile Rheumatoid Arthritis (JRA) is quantifying the degree of disease activity in any given joint. We have built a prototype device using well-established sensors to rapidly quantify surface swelling and heat in arthritic joints. The goal of our studies is to test the hypothesis that this Imager can improve the clinical assessment of arthritis.

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

Not provided

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

157Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Adult RA			Other: 3D and thermal imaging
pediatric JRA			Other: 3D and thermal imaging

Interventions

Name	Type	Description	Arm Group Labels	Other Names
3D and thermal imaging	Other	subjects will be imaged before and after receiving DMARD therapy	Adult RA pediatric JRA

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

at least 4 years of age

Exclusion Criteria:

less than 4 years of age

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

4 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

children with JRA adults with RA

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Pittsburgh		Pittsburgh	Pennsylvania	15224	United States

Condition Browse Module

MeSH Terms

ID	Term
D001172	Arthritis, Rheumatoid
D001171	Arthritis, Juvenile

Ancestor Terms

ID	Term
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases
D012216	Rheumatic Diseases

Browse Leaves

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Browse Branches

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