Assessing the Usability and Clinical Utility of the Congo... | NCT02611011

Studies
Assessing the Usability and Clinical Utility of the Congo Red Dot Test: A Survey

NCT02611011

Sponsor

Gynuity Health Projects

Status

Completed

Last Update Posted

Jan 3, 2019Actual

Enrollment

198Actual

Phase

Not provided

Conditions

Preeclampsia

Interventions

Congo Red Test (GV-005)

Countries

Mexico

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

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2018

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

Mar 1, 2018Actual

Primary Completion Date

Jun 30, 2018Actual

Completion Date

Dec 30, 2018Actual

First Submitted Date

Nov 18, 2015

First Submission Date that Met QC Criteria

Nov 18, 2015

First Posted Date

Nov 20, 2015Estimated

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

Dec 31, 2018

Last Update Posted Date

Jan 3, 2019Actual

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

Detailed Description

To determine if women can understand the instructions, carry out the test, and interpret the test results. Women will be recruited to complete a test instruction and comprehension assessment and a usability assessment. Study participants will be a convenience sample of women seeking health services. Participants will first be asked to review the instructions for the Congo Red Dot Test and complete a short written questionnaire that assesses their comprehension of the test instructions. Participants will then be asked to perform the test using a test control and to interpret the results obtained by answering a second written questionnaire. After the woman performs the test, a healthcare provider will use a matched control to perform a second test.

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

198Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Women		Women seeking health services will perform the Congo Red Dot test (GV-005) individually by following the the test instructions	Device: Congo Red Test (GV-005)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Congo Red Test (GV-005)	Device	The GV-005 is a simple test has been developed to detect unfolded or misfolded proteins in urine.	Women

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
CRD Test Comprehension	proportion of women who demonstrated various levels of understanding of the instructions for the CRD Test	within 5 minutes of reading test instructions

Secondary Outcomes

Measure	Description	Time Frame
CRD Test Usability	the proportion of women able to correctly use the CRD test	within 5 minutes of performing test

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Eligible to consent for research
Able to read Spanish well enough to read the test instructions
Able to give informed consent

Exclusion Criteria:

None

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

10 Years

Maximum Age

50 Years

Standard Ages

ChildAdult

Study Population

Women attending Centre de Salud Beatriz Velasco de Aleman for health services

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Beverly Winikoff, Dr	Gynuity Health Projects	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Centro de Slaud Beatriz Velasco de Aleman		Mexico City			Mexico

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

Type	Date	Date Unknown
Release	Aug 20, 2019
Reset	Sep 19, 2019

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Aug 20, 2019			Sep 19, 2019

Condition Browse Module

MeSH Terms

ID	Term
D011225	Pre-Eclampsia

Ancestor Terms

ID	Term
D046110	Hypertension, Pregnancy-Induced
D011248	Pregnancy Complications
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided