Performance of Tampons as a Biospecimen Collection Tool for the Detection of Human Papillomavirus in a Colposcopy Setting

Launched by TAMPON INNOVATIONS LTD · Jan 6, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at how well a special tampon, called the Daye Diagnostic Tampon (DDT), can detect Human Papillomavirus (HPV), which is linked to certain types of cervical disease. The research aims to see if using this tampon is as effective as a standard method where a clinician collects samples during a procedure called colposcopy. This trial is important because it could offer a more comfortable way for women to be tested for HPV.

To participate in the trial, women aged 25 to 65 who are referred for a routine colposcopy may be eligible. They should be able to understand the information provided about the study and give their consent to join. Participants can expect to use the DDT in a clinical setting and will have their results compared to the standard test taken by a clinician. It’s also important to note that women who are pregnant, have had a hysterectomy, or have certain allergies will not be able to participate. This study is not yet recruiting, so it’s still in the planning stage.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • Individuals aged 25-65 years (inclusive)
• • Ability to understand patient information sheet
• • Ability to provide informed consent
• • Natal female
• • Referred to colposcopy for routine indications
• • In-tact cervix
• Exclusion Criteria:
• • \<25 years of age or over 65 years of age
• • Hysterectomised
• • Known allergy or sensitivity to tampons
• • Pregnancy (current) or within last 3 months
• • History of toxic shock syndrome
• • Concurrent participation in other interventional research project