An interventional study of Self sampling kit for collecting discharge from vaginal fornix in Human Papillomavirus Infection, Self Sampling and Vaginal Discharge, sponsored by Hygeia Touch Inc.. Completed at 3 sites in Taiwan. Open to female participants aged 21 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-10-03.
Sponsored by Hygeia Touch Inc. · Not applicable, Interventional, and Diagnostic
Hygeia Touch Inc. developed a safe and comfortable vaginal self-sampling device "Hygeia Touch Self Sampling Kit for Women" to self-collect the vaginal discharge sample for high-risk Human Papillomavirus (hrHPV) detection.
This clinical trial aimed to evaluate the agreement of hrHPV detections between vaginal self-sampling using "Hygeia Touch Self Sampling Kit for Women" and physician sampling, and these results will be applied for TFDA registration approval.
Primary end-point:
Secondary end-point:
495 studies on the registry are indexed under Papillomavirus Infections; 125 are open to participants now.
This study's enrollment of 1,210 is above the median of 202 across 332 interventional studies indexed under Papillomavirus Infections.
Browse Papillomavirus Infections studies →This is the only study on the registry with Hygeia Touch Inc. as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
We enroll a total of 1,200 women, as follows, 1. 120 cases with no history or current cervical intraepithelial lesion or malignancy. 2. 180 cases with a history of abnormal Pap test including ASCUS, CIN1, or atypical glandular cell. 3. 240 cases with a history of atypical squamous cells favor HSIL, dysplasia cannot exclude HSIL, CIN2, CIN3, cervical carcinoma in situ, squamous cell carcinoma, atypical glandular cells favor neoplasm, adenocarcinoma in situ, or cervical adenocarcinoma. 4. 240 cases with current ASCUS, CIN1, or atypical glandular cell. 5. 420 cases with current abnormal Pap test as atypical squamous cells favor HSIL, dysplasia cannot exclude HSIL, CIN2, CIN3, cervical carcinoma in situ, squamous cell carcinoma, atypical glandular cells favor neoplasm, adenocarcinoma in situ, or cervical adenocarcinoma.
Device: Self sampling kit for collecting discharge from vaginal fornix
A device to collect exfoliative cells from vaginal fornix that can self-operated with ease and comfort.
Also known as: Hygeia Touch Self Sampling Kit for Women
Agreement in the Detection of High-risk HPV Type in Physician-sampled Specimen and Self-collected Specimen.
Rate of the "agreement". The "agreement" is defined as either (1) presence of any high-risk HPV type in physician collected specimen, and the patient sampled specimen, or (2) absence of high-risk HPV in physician collected specimen and the patient sampled specimen.
Time frame: 14 days
Agreement in HPV Detection Between Physician Collected Sample and Self-collected Sample
Rate of the "agreement". The "agreement" is defined as either (1) presence of any HPV type in physician collected specimen, and the patient sampled specimen, or (2) absence of any HPV in physician collected specimen and the patient sampled specimen.
Time frame: 14 days
Percentage of a Valid Specimen, According to the Presence of the Beta-globin Gene in Specimens
Percentage of the presence of the beta-globin gene. The ratio could be calculated between self-collected and physician-collected specimens.
Time frame: 14 days
Adverse Event From Self Sampling
The number of participants with any adverse event.
Time frame: within one month after sample collection
| Milestone | Study Population |
|---|---|
| Started | 1210 |
| Completed | 1210 |
| Not completed | 0 |
Rate of the "agreement". The "agreement" is defined as either (1) presence of any high-risk HPV type in physician collected specimen, and the patient sampled specimen, or (2) absence of high-risk HPV in physician collected specimen and the patient sampled specimen.
| Participants | Self-collected Specimens | Physician-sampled Specimens |
|---|---|---|
| Positive | 581 | 611 |
| Negative | 589 | 559 |
Rate of the "agreement". The "agreement" is defined as either (1) presence of any HPV type in physician collected specimen, and the patient sampled specimen, or (2) absence of any HPV in physician collected specimen and the patient sampled specimen.
| Participants | Self-collected Specimens | Physician-sampled Specimens |
|---|---|---|
| Positive | 718 | 720 |
| Negative | 452 | 450 |
Percentage of the presence of the beta-globin gene. The ratio could be calculated between self-collected and physician-collected specimens.
| Participants | Self-collected Specimens | Physician-sampled Specimens |
|---|---|---|
| Percentage of a Valid Specimen, According to the Presence of the Beta-globin Gene in Specimens | 1170 | 1170 |
The number of participants with any adverse event.
| Participants | Women Participated in Self-sampling |
|---|---|
| Adverse Event From Self Sampling | 9 |
Collected over 1 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Participants With Adverse Events | 0/1,210 (0%) | 0/1,210 (0%) | 9/1,210 (0.7%) |
| Event | Participants With Adverse Events |
|---|---|
| Perineal painProduct Issues | 7/1210 |
| anxietyProduct Issues | 2/1210 |
| Age, Continuous(years) | Study Population |
|---|---|
| Mean | 45.3 ± 10.2 |
| Sex: Female, Male(Participants) | Study Population |
|---|---|
| Female | 1210 |
| Male | 0 |
| Race and Ethnicity Not Collected(Participants) | Study Population |
|---|
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — For clinical trial participation.
Supporting information: Sap, Icf, Csr
This study is completed, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.
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