PregnancyPreview® hCGNCT04207554
Clinical Investigation for the Preview® hCG Urine/Serum Combo Pregnancy Test
An observational study of Pregnancy, run by Guangzhou Wondfo Biotech Co., Ltd at 6 sites in United States.
Trial summary
The objective of this study is to evaluate the agreement of the test device (Preview® hCG Urine/Serum Combo Pregnancy Test) with the predicate device, the QuickVue+ hCG Combo Test. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy
- What is being tested?
- Test Device-Strip Format, Test Device-Cassette Format and Predicate Device
- Type of treatment
- Medical device
- How many people
- 132 participants
- Where
- 6 sitesUnited States
- Study dates
- 5 Dec 2019to 29 Dec 2020
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study will enroll healthy adult women of childbearing age.
Who may be able to join
- Healthy adult women of childbearing age.
- Who either request a pregnancy test, or require a pregnancy test for diagnostic studies or treatment.
- Signed and dated informed consent.
Who cannot join
- Minors.
- Adults who are unable to independently give consent for study.
- Known pregnancy (i.e. - patient appears obviously pregnant).
- Recent miscarriage or abortion and yet to have 2 complete menstrual cycles before study start.
- History of ectopic pregnancy, fibroids, congenital uterine anomaly that causes an irregular-shaped uterus.
- Taken any of the medications of contraceptives containing estrogen in last two weeks.
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- Hemodynamically unstable.
- Moderately to severely ill-appearing or in moderate to severe pain.
- Technically not possible to obtain blood or urine from the study subject.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
National Insitute of Clinical Research
Garden Grove, California, 92844
National Research Institute-Huntington Park
Huntington Park, California, 90255
Downtown L.A. Research Center, Inc
Los Angeles, California, 90017
National Research Institute-Westlake
Los Angeles, California, 90057
National Research Institute-Panorama City
Panorama City, California, 91402
National Research Institute-Santa Ana
Santa Ana, California, 92704
About this study
The objective of this study is to evaluate the agreement of the test device (Preview® hCG Urine/Serum Combo Pregnancy Test) with the predicate device, the QuickVue+ hCG Combo Test.
- Conditions
- Pregnancy
- Being tested
- Test Device-Strip Format, Test Device-Cassette Format, Predicate Device
- Keywords
- Pregnancy, hCG, IVD, POCT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Test Device-Strip FormatDevice
Also called Preview® hCG Urine/Serum Combo Pregnancy Test-Strip Format
Sponsor's investigational device
Test Device-Cassette FormatDevice
Also called Preview® hCG Urine/Serum Combo Pregnancy Test-Cassette Format
Sponsor's investigational device
Predicate DeviceDevice
Also called QuickVue+ hCG Combo Test
Commercially available device
| Study group | Role | What they receive |
|---|---|---|
| Pregnancy Positive | Pregnant subjects within 11 weeks since the first day of last period. Receives: Device: Test Device-Strip Format; Device: Test Device-Cassette Format; Device: Predicate Device | |
| Pregnancy Negative | Non-pregnant subjects. Receives: Device: Test Device-Strip Format; Device: Test Device-Cassette Format; Device: Predicate Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall percent (%) agreement
The primary endpoint is the overall percent (%) agreement, which is the percentage of total subjects where the test (Preview® hCG Urine/Serum Combo Pregnancy Test) and the reference test (QuickVue+ hCG Combo Test) agree.
Measured: 3 months
Secondary outcomes (1)
Positive and negative percent agreement
The secondary endpoint is the positive percent agreement and negative percent agreement.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2019
- Study start5 Dec 2019
- Primary completion29 Dec 2020
- Study completion29 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guangzhou Wondfo Biotech Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Nova Clinical Solutions, Inc.
- Responsible party
- Sponsor
- Investigators
- Rui Liu, Master, Study chair, Guangzhou Wondfo Biotech Co., Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04207554
- Sponsor's protocol ID
- WF2019-01
- Acronym
- Preview® hCG
- Status last verified
- Jan 2021
- First submitted
- 18 Dec 2019
- Last updated
- 11 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
WIDE L, GEMZELL CA. An immunological pregnancy test. Acta Endocrinol (Copenh). 1960 Oct;35:261-7. doi: 10.1530/acta.0.xxxv0261. No abstract available.
PubMed 13785019Batzer FR. Hormonal evaluation of early pregnancy. Fertil Steril. 1980 Jul;34(1):1-13. doi: 10.1016/s0015-0282(16)44829-6. No abstract available.
PubMed 6995156Braunstein GD, Rasor J, Danzer H, Adler D, Wade ME. Serum human chorionic gonadotropin levels throughout normal pregnancy. Am J Obstet Gynecol. 1976 Nov 15;126(6):678-81. doi: 10.1016/0002-9378(76)90518-4.
PubMed 984142Braunstein GD, Vaitukaitis JL, Carbone PP, Ross GT. Ectopic production of human chorionic gonadotrophin by neoplasms. Ann Intern Med. 1973 Jan;78(1):39-45. doi: 10.7326/0003-4819-78-1-39. No abstract available.
PubMed 4734160Catt KJ, Dufau ML, Vaitukaitis JL. Appearance of hCG in pregnancy plasma following the initiation of implantation of the blastocyst. J Clin Endocrinol Metab. 1975 Mar;40(3):537-40. doi: 10.1210/jcem-40-3-537.
PubMed 1117063Lenton EA, Neal LM, Sulaiman R. Plasma concentrations of human chorionic gonadotropin from the time of implantation until the second week of pregnancy. Fertil Steril. 1982 Jun;37(6):773-8. doi: 10.1016/s0015-0282(16)46337-5.
PubMed 7115557
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Investigation for the Preview® hCG Urine/Serum Combo Pregnancy Test
- ClinicalTrials.gov ID
- NCT04207554
- Acronym / sponsor ID
- Preview® hCG / WF2019-01
- Conditions
- Pregnancy
- Keywords
- Pregnancy, hCG, IVD, POCT
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- Guangzhou Wondfo Biotech Co., LtdIndustry (pharma, biotech, devices)
- Collaborators
- Nova Clinical Solutions, Inc.
- Study start
- 5 Dec 2019 (actual)
- Primary completion
- 29 Dec 2020 (actual)
- Study completion
- 29 Dec 2020 (actual)
- First posted
- 23 Dec 2019 (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.
The objective of this study is to evaluate the agreement of the test device (Preview® hCG Urine/Serum Combo Pregnancy Test) with the predicate device, the QuickVue+ hCG Combo Test.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pregnancy Positive | – | Device: Test Device-Strip Format, Device: Test Device-Cassette Format, Device: Predicate DevicePregnant subjects within 11 weeks since the first day of last period. |
| Pregnancy Negative | – | Device: Test Device-Strip Format, Device: Test Device-Cassette Format, Device: Predicate DeviceNon-pregnant subjects. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study will enroll healthy adult women of childbearing age.
Key inclusion criteria (3 listed)
- Healthy adult women of childbearing age.
- Who either request a pregnancy test, or require a pregnancy test for diagnostic studies or treatment.
- Signed and dated informed consent.
Key exclusion criteria (9 listed)
- Minors.
- Adults who are unable to independently give consent for study.
- Known pregnancy (i.e. - patient appears obviously pregnant).
- Recent miscarriage or abortion and yet to have 2 complete menstrual cycles before study start.
- History of ectopic pregnancy, fibroids, congenital uterine anomaly that causes an irregular-shaped uterus.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Test Device-Strip FormatAlso: Preview® hCG Urine/Serum Combo Pregnancy Test-Strip FormatSponsor's investigational device | Device | Pregnancy Negative, Pregnancy Positive |
| Test Device-Cassette FormatAlso: Preview® hCG Urine/Serum Combo Pregnancy Test-Cassette FormatSponsor's investigational device | Device | Pregnancy Negative, Pregnancy Positive |
| Predicate DeviceAlso: QuickVue+ hCG Combo TestCommercially available device | Device | Pregnancy Negative, Pregnancy Positive |
Primary outcome
Overall percent (%) agreement
Time frame: 3 months
The primary endpoint is the overall percent (%) agreement, which is the percentage of total subjects where the test (Preview® hCG Urine/Serum Combo Pregnancy Test) and the reference test (QuickVue+ hCG Combo Test) agree.
1 secondary outcome
Positive and negative percent agreement
Time frame: 3 months
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 11 Jan 2021.
- Results publication: PubMed 13785019WIDE L, GEMZELL CA. An immunological pregnancy test. Acta Endocrinol (Copenh). 1960 Oct;35:261-7. doi: 10.1530/acta.0.xxxv0261. No abstract available.
- Results publication: PubMed 6995156Batzer FR. Hormonal evaluation of early pregnancy. Fertil Steril. 1980 Jul;34(1):1-13. doi: 10.1016/s0015-0282(16)44829-6. No abstract available.
- Results publication: PubMed 984142Braunstein GD, Rasor J, Danzer H, Adler D, Wade ME. Serum human chorionic gonadotropin levels throughout normal pregnancy. Am J Obstet Gynecol. 1976 Nov 15;126(6):678-81. doi: 10.1016/0002-9378(76)90518-4.
- Results publication: PubMed 4734160Braunstein GD, Vaitukaitis JL, Carbone PP, Ross GT. Ectopic production of human chorionic gonadotrophin by neoplasms. Ann Intern Med. 1973 Jan;78(1):39-45. doi: 10.7326/0003-4819-78-1-39. No abstract available.
- Results publication: PubMed 1117063Catt KJ, Dufau ML, Vaitukaitis JL. Appearance of hCG in pregnancy plasma following the initiation of implantation of the blastocyst. J Clin Endocrinol Metab. 1975 Mar;40(3):537-40. doi: 10.1210/jcem-40-3-537.
- Results publication: PubMed 7115557Lenton EA, Neal LM, Sulaiman R. Plasma concentrations of human chorionic gonadotropin from the time of implantation until the second week of pregnancy. Fertil Steril. 1982 Jun;37(6):773-8. doi: 10.1016/s0015-0282(16)46337-5.
- Individual participant dataSharing planned: No
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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.
Rui Liu, Master study chair
Guangzhou Wondfo Biotech Co., Ltd
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy, run by Guangzhou Wondfo Biotech Co., Ltd at 6 sites in United States.
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 3 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 11 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. 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?
Overall percent (%) agreement (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04207554, which also lists 6 linked publications.
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 11 Jan 2021.