Feasibility of the Oricol™ Sampling Device to Retrieve Vagina Mucus (Wall) Samples for Genomic & Epigenetic Analysis.

Primary ObjectiveThe primary objective is to explore the feasibility of collecting a vaginal sample using the OriCol™ Sampling Device.Secondary ObjectivesThe study has secondary objectives to assess:Acceptability of the sampling technique to both patient and clinicianTo understand the balloon volume (maximum 80ml) required for effective intra-vaginal sampling.Participant feedback during and after the test for using the OriCol™ Sampling Device using a Visual Analogue ScalePatient discrete choice of Oricol™ versus speculum examination.

Inclusion Criteria: All participants must meet the following criteria to be eligible for the study:Aged 18 years or overAble to give voluntary, written informed consent to participate in the studyAttending a Gynaecology Outpatient ClinicUndergoing vaginal speculum examination as part of their routine clinical careExclusion Criteria: The following exclusion criteria are appliedVaginal, vulval or perineal symptoms make vaginal examination inappropriate.Penetrative vaginal sex within the last 24 hoursAllergy to barrier contraceptionHistory of allergic reactions to polypropylene and/or nitrilePregnant or suspicion of pregnancyParticipation in an interventional or pharmaceutical clinical study if treatment/intervention has already commencedPreviously had a hysterectomyPreviously had pelvic cancerPreviously had chemotherapy or pelvic radiotherapyCurrently undergoing hormone-based treatment for breast or other cancerWomen with known Hepatitis B, Hepatitis C, HIV or HTLV-II infection, or any other similarly classified human pathogen including prion diseases (Creutzfeldt-Jakob disease).