Optical Elastography of Systemic Sclerosis Skin | NCT02835196

Studies
Optical Elastography of Systemic Sclerosis Skin

NCT02835196

Sponsor

The University of Texas Health Science Center, Houston

Status

Completed

Last Update Posted

Feb 25, 2020Actual

Enrollment

12Actual

Phase

Not provided

Conditions

Scleroderma

Interventions

Optical Elastography
Visual Assessment

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
PR150338	Other Grant/Funding Number	Congressionally Directed Medical Research Program

Status Module

Record Verification Date

Feb 2020

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

Oct 25, 2017Actual

Primary Completion Date

Nov 1, 2018Actual

Completion Date

Nov 1, 2018Actual

First Submitted Date

Jul 13, 2016

First Submission Date that Met QC Criteria

Jul 13, 2016

First Posted Date

Jul 15, 2016Estimated

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

Feb 21, 2020

Last Update Posted Date

Feb 25, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Shervin Assassi, Associate Professor, The University of Texas Health Science Center, HoustonPrincipal Investigator

Lead Sponsor

The University of Texas Health Science Center, HoustonOTHER

Collaborators

Name	Class
University of Houston	OTHER

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

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The goal of this study is to develop a new way to assess skin thickness in patients with scleroderma (systemic sclerosis). The study will test how well a new imaging method called optical coherence elastography (OCE) compares to the current clinical method used to estimate skin thickness, the modified Rodnan Skin Score (mRSS).

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

Retention

Enrollment

12Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Optical Elastography Assessment of Skin Thickness			Device: Optical Elastography
Visual Assessment of Skin Thickness			Other: Visual Assessment

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Optical Elastography	Device	To image skin thickness, Optical Coherence Elastography (OCE)-scanning of 6 body surface areas will be preformed using the Phase-Stabilized Swept Source Optical Coherence Elastography (PhS-SSOCE) system.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Skin optical elastography (OCE) scan score		Baseline

Secondary Outcomes

Measure	Description	Time Frame
Skin thickness as assessed by Modified Rodnan Skin Score (mRSS)		Baseline
Fibrosis score as assessed by forearm skin punch biopsy	A score based on histological findings of skin punch biopsy will be calculated. There some minor risk involved with skin biopsy procedure.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria for scleroderma patients:

meet the 2013 American College of Rheumatology and the European League Against Rheumatism (ACR/EULAR) criteria for systemic sclerosis with limited or diffuse cutaneous involvement

Exclusion Criteria:

have another skin disease other than systemic sclerosis

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Patients seen in clinic.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Shervin Assassi, MD	The University of Texas Health Science Center, Houston	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The University of Texas Health Science Center at Houston		Houston	Texas	77030	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D045743	Scleroderma, Diffuse

Ancestor Terms

ID	Term
D012595	Scleroderma, Systemic
D003240	Connective Tissue Diseases
D017437	Skin and Connective Tissue Diseases
D012871	Skin Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D006804	Ergonomics

Ancestor Terms

ID	Term
D004738	Engineering
D013676	Technology, Industry, and Agriculture

Browse Leaves

Not provided

Browse Branches

Not provided