Status:
NOT_YET_RECRUITING
Performance of Tampons as a Biospecimen Collection Tool for the Detection of Human Papillomavirus in a Colposcopy Setting
Lead Sponsor:
Tampon Innovations Ltd
Collaborating Sponsors:
University of Edinburgh
NHS Lothian
Conditions:
CIN2
Eligibility:
FEMALE
25-65 years
Phase:
NA
Brief Summary
Evaluation of the clinical performance of the Daye Diagnostic Tampon (DDT) for the detection of Human Papilloma Virus (HPV) infection associated with high grade cervical disease. Cross sectional desig...
Detailed Description
Type of Study: Clinical Trial Goal: The goal of this clinical trial is to evaluate the clinical performance of the Daye Diagnostic Tampon (DDT) for the detection of HPV infection associated with high...
Eligibility Criteria
Inclusion
- 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
- \<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
Key Trial Info
Start Date :
February 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2025
Estimated Enrollment :
250 Patients enrolled
Trial Details
Trial ID
NCT06210074
Start Date
February 1 2024
End Date
January 1 2025
Last Update
February 14 2024
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