Clinical Trials Logo

Clinical Trial Summary

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.


Clinical Trial Description

Primary end-point: 1. Agreement of hr-HPV types, including types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68, between the physician-collected sample and self-collected sample 2. Agreement of the presence of hr-HPV between the physician-collected sample and self-collected sample Secondary end-point: 1. Percentage of the valid sample between self-collected and physician-collected specimens 2. Agreement of all (N = 27) HPV types between the paired samples 3. Adverse events associated with sample collection 4. Questionnaire of the appreciation and satisfaction of using self-collecting vaginal discharge sample using "Hygeia Touch Self Sampling Kit for Women" through a short movie and a brief illustration 5. Correlation between histological diagnosis and HPV types ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04472377
Study type Interventional
Source Hygeia Touch Inc.
Contact
Status Completed
Phase N/A
Start date May 29, 2020
Completion date April 18, 2022

See also
  Status Clinical Trial Phase
Completed NCT05458869 - Evaluating the Human Papillomavirus Self-Collection Experience in Individuals Who Have Experienced Sexual Trauma
Completed NCT01932697 - Radiation Therapy and Docetaxel in Treating Patients With HPV-Related Oropharyngeal Cancer Phase 2
Completed NCT03265743 - HPV Vaccination in Women With Cystic Fibrosis N/A
Completed NCT00543543 - Broad Spectrum HPV (Human Papillomavirus) Vaccine Study in 16-to 26-Year-Old Women (V503-001) Phase 3
Recruiting NCT04226313 - Self-sampling for Non-attenders to Cervical Cancer Screening N/A
Completed NCT06199128 - Efficacy and Safety of Carboxymethyl Beta-glucan and Policarbophil in HPV Positive Patients
Active, not recruiting NCT01824537 - Transmission Reduction and Prevention With HPV Vaccination (TRAP-HPV) Study Phase 4
Unknown status NCT01087164 - Brief Interventions to Increase HPV Vaccine Acceptance in School-based Health Centers N/A
Completed NCT01265212 - Prevalence of Human Papillomavirus in Men Living in the Northern Plains N/A
Terminated NCT01082861 - Efficacy and Immunomodulation Study of Simultaneous Human Papillomavirus/ Hepatitis B (HPV/HBV) Vaccination Phase 4
Completed NCT00572832 - Randomized Trial of Alternative Quadrivalent Human Papilloma Virus (HPV) Vaccination Schedules in a University Setting N/A
Completed NCT03158220 - Immunogenicity and Tolerability of Broad Spectrum Human Papillomavirus (HPV) Vaccine in Adult and Young Adult Women (V503-004) Phase 3
Recruiting NCT05210348 - Clinical Evaluation of Detection of High Risk HPV in Urine
Completed NCT05680454 - A Phase I Trial Evaluate the Safety and Tolerability Profile of HPV Vaccine Phase 1
Completed NCT04133610 - HPVPro Study: Comparison of HPV Detection in Clinician-collected Cervical Swabs and Self-sampled Cervicovaginal Swabs N/A
Completed NCT00988884 - A Study of V503 Given Concomitantly With Menactra™ and Adacel™ in 11 to 15 Year Olds (V503-005) Phase 3
Not yet recruiting NCT05981807 - HPV Infection, Sexually Transmitted Infections and Anal Dysplasia in the Transgender Population
Recruiting NCT03302858 - A Safety and Efficacy Trial of Circumferential Anal Canal Radiofrequency Ablation for High-Grade Anal Intraepithelial Neoplasia Using the BARRX™ Anorectal Wand Phase 2
Completed NCT01694875 - Clinical Evaluation of the APTIMA® HPV 16 18/45 Genotype Assay on the PANTHER® System N/A
Completed NCT01158209 - An Observational, Epidemiological Study on the Prevalence of Human Papillomavirus Types in Women in Egypt N/A