NCT06210074

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 250 (estimated)
• Sponsor: Tampon Innovations Ltd · Industry
• Sex: Female
• Age: 25 Years – 65 Years
• Healthy volunteers: Accepted

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 design with comparison to a clinician taken biospecimen. Performance will be measured relative to the presence/absence of histologically confirmed disease

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-grade cervical disease. Main Questions: What is the sensitivity and specificity of molecular HPV assays in detecting high-grade cervical disease (CIN2+) using the DDT compared to a clinician-taken, liquid-based cytology (LBC) sample? How does the relative sensitivity and specificity of HPV detection in the tampon compare to the LBC sample for the detection of CIN2+? Participants: Women attending routine colposcopy clinics as part of standard care. Main Tasks: Provide informed consent. Undergo routine colposcopy. Use the DAYE Diagnostic Tampon (DDT). Provide a clinician-taken liquid-based cytology (LBC) sample. Complete a short questionnaire. Comparison Group: Researchers will compare the performance of the DAYE Diagnostic Tampon (DDT) to a clinician-taken, liquid-based cytology (LBC) sample to determine if there are differences in sensitivity and specificity for the detection of high-grade cervical disease (CIN2+). The comparison will assess the relative sensitivity and specificity of HPV detection in the tampon versus the LBC sample for the presence/absence of histologically confirmed disease.

Conditions

• CIN2

Interventions

Type	Name	Description
DEVICE	Daye Diagnostic Tampon	The DAYE Diagnostic Tampon is a class A in vitro diagnostic device. It has CE certification (self-certified via a declaration of conformity, following the IVDR (EU) 2017/746). The DDT is constructed entirely from woven cotton and consists of an absorbent core wrapped in a protective sleeve. The DDT is loaded in an applicator to aid with insertion. The DDT needs to be worn for 20 minutes then when removed should be placed immediately in the sterile container.

Timeline

• Start date: 2024-02-01
• Primary completion: 2024-12-01
• Completion: 2025-01-01
• First posted: 2024-01-18
• Last updated: 2024-02-14