The Agreement of hrHPV Detections Between Vaginal Self-sampling and Physician Sampling

  • STATUS
    Recruiting
  • participants needed
    1200
  • sponsor
    Hygeia Touch Inc.
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Updated on 19 February 2024
See if I qualify
cancer
hysterectomy
adenocarcinoma
carcinoma
pap smear
dysplasia
human papillomavirus
cervical disease
cervical carcinoma
hsil
cervical intraepithelial neoplasia grade 2
cin 2
cervical intraepithelial neoplasia
intraepithelial neoplasia
carcinoma in situ of cervix
adenocarcinoma in situ
cervical intraepithelial neoplasia grade 1

Summary

Hygeia Touch Inc. has developed a safe and comfortable vaginal self-sampling device "Hygeia Touch Self Sampling Kit for Women" to self-collect the vaginal samples 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.

Details
Condition Vaginal Discharge, Human Papillomavirus Infection, Self Sampling
Age 21years - 65years
Treatment Self sampling kit for collecting discharge from vaginal fornix
Clinical Study IdentifierNCT04472377
SponsorHygeia Touch Inc.
Last Modified on19 February 2024

Eligibility

 Yes No Not Sure

Inclusion Criteria

Woman with a uterine cervix, i.e., with no previous total hysterectomy or radiotherapy for cervical tumor. The woman who received subtotal hysterectomy is allowed
Signed informed consent. 3. Fit any one of the following conditions
with no history or current cervical intraepithelial lesion or malignancy
with a history of abnormal Pap test including atypical squamous cells of undetermined significance, cervical intraepithelial neoplasia grade 1, or atypical glandular cell
with a history of atypical squamous cells favor high-grade squamous intraepithelial lesion, dysplasia cannot exclude high-grade squamous intraepithelial lesion, cervical intraepithelial neoplasia grade 2, cervical intraepithelial neoplasia grade 3, cervical carcinoma in situ, squamous cell carcinoma, atypical glandular cells favor neoplasm, adenocarcinoma in situ, or cervical adenocarcinoma
with current atypical squamous cells of undetermined significance, cervical intraepithelial neoplasia grade 1, or atypical glandular cell
with current abnormal Pap test as atypical squamous cells favor high-grade squamous intraepithelial lesion, dysplasia cannot exclude high-grade squamous intraepithelial lesion, cervical intraepithelial neoplasia grade 2, cervical intraepithelial neoplasia grade 3, cervical carcinoma in situ, squamous cell carcinoma, atypical glandular cells favor neoplasm, adenocarcinoma in situ, or cervical adenocarcinoma

Exclusion Criteria

History of total hysterectomy
Pregnant
Current cervicitis that requires therapy
Received treatment for cervical lesion within 90 days
Had undergone radiotherapy or is receiving radiation over the uterus, cervix or vagina
Had sexual activity without a condom in 48 hours
Excessive vaginal discharge, either in the ovulation period or due to inflammation
is undergoing local therapy with an intravaginal tablet or residual drug in the vaginal canal
during mense
Clear my responses
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Similar trials to consider

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cancer
hysterectomy
adenocarcinoma
carcinoma
pap smear
dysplasia
human papillomavirus
cervical disease
cervical carcinoma
hsil
cervical intraepithelial neoplasia grade 2
cin 2
cervical intraepithelial neoplasia
intraepithelial neoplasia
carcinoma in situ of cervix
adenocarcinoma in situ
cervical intraepithelial neoplasia grade 1

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