Early PregnancyNCT06228118
Clinical Trail of the Lay User Study and Method Comparison Study of Human Chorionic Gonadotropin (HCG) Test System
An observational study of Early Pregnancy, run by Andon Health Co., Ltd at 1 site in China.
Trial summary
This clinical trial consisted of lay user study and method comparison study. Method comparison study: evaluate the clinical performance by comparing the results of new device and FDA cleared device (the comparator) tested on the same sample by professionals. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Early Pregnancy
- How many people
- 502 participants
- Where
- 1 siteChina
- Study dates
- 4 Aug 2023to 2 Sep 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: A total of 502 subjects with ages from 18-55 years old were enrolled . Among the 502 total subjects, 369 subjects aged between 18 and 55 years old voluntarily participated in the Lay User Study.
Who may be able to join
- Method comparison study exclusion criteria
- Female；
- 18-55 years of age；
- Voluntary and sign informed consent form.
- Lay user study inclusion criteria
- Female；
Show all 10Show fewer
- 18-55 years of age；
- Voluntary and sign informed consent form；
- Willingness to perform self-test of investigational device；
- Have the ability to read English.
Who cannot join
- Method comparison study exclusion criteria
- Use of hCG-containing fertility medications (e.g., Pregnyl, Profasi, Novarel, Ovidrel)；
- Within 8 weeks of childbirth or abortion；
- The investigator has reason to believe that it is inappropriate for subjects to participate in the study.
- Lay user study inclusion criteria
- Use of hCG-containing fertility medications (e.g., Pregnyl, Profasi, Novarel, Ovidrel)；
Show all 9Show fewer
- Within 8 weeks of childbirth or abortion；
- The investigator has reason to believe that it is inappropriate for subjects to participate in the study；
- Background in a medical or laboratory testing.
Trial locations and contacts
1 site in 1 country.
China1 site
First Teaching hospital of Tianjin University of Traditional Chinese Medicine
Tianjin
About this study
This clinical trial consisted of lay user study and method comparison study. Method comparison study: evaluate the clinical performance by comparing the results of new device and FDA cleared device (the comparator) tested on the same sample by professionals.
Lay user study: evaluate the usability of by comparing the results of new device on the same sample tested by professionals and lay user, and by lay users complete the questionnaire.
- Conditions
- Early Pregnancy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Subjects enrolled in method comparison study only | Not described | |
| Subjects enrolled in both the method comparison study and lay user study | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison results
Compare the test results conducted by professionals using investigational device and the comparator, and the positive percent agreement (PPA=100%), negative percent agreement (NPA=100%) and overall percent agreement (OPA=100%) were calculated.
Measured: 30minute
Secondary outcomes (1)
Evaluate the usability and user comprehension of investigational device
The accuracy rate of the critical task is 100%. The Overall Percent Agreement for investigational device is 100% when conducted by a lay user. The accuracy rate of the each questions in the Knowledge assessment is 100%, and 100% of the Ease of operation assessment chose normal, easy, or very easy.
Measured: 30minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2024
- Study start4 Aug 2023
- Primary completion2 Sep 2023
- Study completion2 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Early PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 502 participants (actual)
Sponsor and investigators
- Lead sponsor
- Andon Health Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06228118
- Sponsor's protocol ID
- IHC-3000-LCFA01
- Status last verified
- Jan 2024
- First submitted
- 19 Jan 2024
- Last updated
- 30 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trail of the Lay User Study and Method Comparison Study of Human Chorionic Gonadotropin (HCG) Test System
- ClinicalTrials.gov ID
- NCT06228118
- Acronym / sponsor ID
- IHC-3000-LCFA01
- Conditions
- Early Pregnancy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 502 participants (actual)
- Lead sponsor
- Andon Health Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 4 Aug 2023 (actual)
- Primary completion
- 2 Sep 2023 (actual)
- Study completion
- 2 Sep 2023 (actual)
- First posted
- 29 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This clinical trial consisted of lay user study and method comparison study. Method comparison study: evaluate the clinical performance by comparing the results of new device and FDA cleared device (the comparator) tested on the same sample by professionals.
Lay user study: evaluate the usability of by comparing the results of new device on the same sample tested by professionals and lay user, and by lay users complete the questionnaire.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Subjects enrolled in method comparison study only | – | – |
| Subjects enrolled in both the method comparison study and lay user study | – | – |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- A total of 502 subjects with ages from 18-55 years old were enrolled . Among the 502 total subjects, 369 subjects aged between 18 and 55 years old voluntarily participated in the Lay User Study.
Key inclusion criteria (10 listed)
- Method comparison study exclusion criteria
- Lay user study inclusion criteria
Key exclusion criteria (9 listed)
- Method comparison study exclusion criteria
- Lay user study inclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Comparison results
Time frame: 30minute
Compare the test results conducted by professionals using investigational device and the comparator, and the positive percent agreement (PPA=100%), negative percent agreement (NPA=100%) and overall percent agreement (OPA=100%) were calculated.
1 secondary outcome
Evaluate the usability and user comprehension of investigational device
Time frame: 30minute
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Early Pregnancy, run by Andon Health Co., Ltd at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison results (time frame: 30minute). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2024.