Detection of Urinary Human Chorionic Gonadotropin (hCG) | NCT05458778

Studies
Detection of Urinary Human Chorionic Gonadotropin (hCG)

NCT05458778

Sponsor

Quanovate Tech Inc.

Status

Unknown status

Last Update Posted

May 1, 2023Actual

Enrollment

200Estimated

Phase

Not provided

Conditions

Pregnancy Detection

Interventions

Daily test with urine by the product

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 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 29, 2022Actual

Primary Completion Date

Oct 31, 2023Estimated

Completion Date

Oct 31, 2023Estimated

First Submitted Date

Jul 4, 2022

First Submission Date that Met QC Criteria

Jul 11, 2022

First Posted Date

Jul 14, 2022Actual

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 27, 2023

Last Update Posted Date

May 1, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

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 Mira Pregnancy Test is an over-the-counter urine hCG test intended for early detection of pregnancy. The test is indicated for use four days before the expected period. Throughout this study, volunteers with non-medical backgrounds were recruited to test hCG with urine samples using the Mira Pregnancy Test during the not pregnancy cycle or pregnancy cycle. To perform the study, a total number of more than 200 volunteers will be recruited to participate in the study.

Detailed Description

The studies include two parts, which are a lay user study and a urine samples test during the trying to conceive cycle.

Part 1: Lay user study Part 2: Detection of hCG in Early Pregnancy Clinical Samples

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

200Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Women who are trying to conceive			Device: Daily test with urine by the product

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Daily test with urine by the product	Device	Women perform the hCG test and share the test results	Women who are trying to conceive

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Cognitive evaluation via survey and calculating the consistency	The consistency between the lay-user test results and the actual test results	From July 2022 to August 2022
The accuracy of data was expressed as per the Pregnancy Detection Rate	The number of positive results on different days obtained by the user of the Mira pregnancy test is divided by the total number of women who confirmed pregnancy.	From July 2022 to August 2022

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Female
Aged 18 and over
Willing to give informed consent
Willing to conduct a personal home pregnancy test and reveal their pregnancy status
Have a working smartphone

Exclusion Criteria:

Have a medical background or have been in a related industry/occupation
Volunteers who are unfit to participate in the research by the researcher
Used the investigational pregnancy test previously
Has a medical condition
Confirmed to be pregnant by a healthcare professional and beyond the first trimester (defined as last menstrual period (LMP) +13 weeks)

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Include more than 200 worldwide women aged 18 and over taking part in this study.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Zheng Yang, PhD	Contact	+1 4125197085		zyang@quanovate.com

Overall Officials

Name	Affiliation	Role
Ning Li, MS	Quanovate Tech Inc.	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Quanovate Tech Inc.	Recruiting	San Ramon	California	94583	United States