Ultrasound B Mode Imaging and Elastography | NCT04607187

Studies
Ultrasound B Mode Imaging and Elastography

NCT04607187

Sponsor

Theresa Bass-Goldman

Status

Completed

Last Update Posted

Oct 29, 2020Actual

Enrollment

20Actual

Phase

Not provided

Conditions

Dupuytren's Contractures

Interventions

Not provided

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

Oct 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

Nov 2013Actual

Primary Completion Date

Nov 2014Actual

Completion Date

Dec 2014Actual

First Submitted Date

Nov 22, 2013

First Submission Date that Met QC Criteria

Oct 22, 2020

First Posted Date

Oct 29, 2020Actual

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

Oct 22, 2020

Last Update Posted Date

Oct 29, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Theresa Bass-Goldman, Principal Investigator Paul J. DeMarco, MD, Arthritis & Rheumatism Associates, P.C.Sponsor-Investigator

Lead Sponsor

Theresa Bass-GoldmanOTHER

Collaborators

Name	Class
Endo USA Inc., a Keenova Therapeutics Company	INDUSTRY

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

A Pilot Study on Ultrasound B mode Imaging and Elastography during administration of Xiaflex (collagenase clostridium histolyticum) for Dupuytren's contracture.

Detailed Description

Ultrasound analysis will be obtained on patient that receives Xiaflex as standard of care for Dupuytren's contracture

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

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Normals, Dupuytren's subjects with and without treatment		Ultrasound analysis of patient receiving treatment for Dupuytren's

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Ultrasound B mode Imaging and Elastography	A Pilot Study: Ultrasound B mode Imaging and Elastography during administration of Xiaflex	30 day trial

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Normal Hand or Hand Dupuytren's contracture

Exclusion Criteria:

Previous treatment of Dupuytren's cord

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

99 Years

Standard Ages

AdultOlder Adult

Study Population

Three groups of people will take part in the research:

5-Normal subjects without a Dupuytren's contracture 5-Subjects that have a hand Dupuytren's contracture that will not receive tx 10-Subjects that have a hand Dupuytren's contracture that will receive tx

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The Center for Rheumatology and Bone Research a division of Arthritis and Rheumatism Associates, P.C.		Wheaton	Maryland	20902	United States