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

NCT05709119 | Completed

• 1 other identifier: Ellele-01
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

Primary Objective The primary objective is to explore the feasibility of collecting a vaginal sample using the OriCol™ Sampling Device. Secondary Objectives The study has secondary objectives to assess:

1. 1.Acceptability of the sampling technique to both patient and clinician
2. 2.To understand the balloon volume (maximum 80ml) required for effective intra-vaginal sampling.
3. 3.Participant feedback during and after the test for using the OriCol™ Sampling Device using a Visual Analogue Scale
4. 4.Patient discrete choice of Oricol™ versus speculum examination.

Conditions

Vagina Disease; Diagnosis

Outcome Measures

Primary Outcomes (1)

• The primary objective is to explore the feasibility of collecting an assessable vaginal sample using the OriCol™ Sampling Device.

  Quantification of human DNA retrieved.

  Within 3 months of completion of recruitment

Secondary Outcomes (3)

• Acceptability of the sampling technique to both patient and clinician

  Immediate from test performance

• To understand the balloon volume (maximum 80ml) required for effective intra-vaginal sampling.

  Within 3 months

• Participant feedback during and after the test for using the OriCol™ Sampling Device using a Visual Analogue Scale

  Immediate from test performance

Interventions

Quantification of human DNA retrieved and DNA fragmentation profile. DIAGNOSTIC_TEST

The sample will be analysed for material quality and have no impact on the patient's future care.

Eligibility Criteria

• Age: 18 Years - 99 Years
• Gender Eligibility Details: As an intravaginal examination technique, the presence of a natural vagina is required.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients will be enrolled until 40 samples have been collected and confirmed assessable by the sponsor. Estimated that 45 recruits will be required to collect 40 assessable samples. For this study, 40 Participant samples will be sufficient to fulfil the objectives of the clinical study. The aim is to obtain a variety of samples from pre-, peri- and post-menopausal women to understand if the change in menopausal status affects device acceptability.

You may qualify if:

• Aged 18 years or over
• Able to give voluntary, written informed consent to participate in the study
• Attending a Gynaecology Outpatient Clinic
• Undergoing vaginal speculum examination as part of their routine clinical care

You may not qualify if:

• Vaginal, vulval or perineal symptoms make vaginal examination inappropriate.
• Penetrative vaginal sex within the last 24 hours
• Allergy to barrier contraception
• History of allergic reactions to polypropylene and/or nitrile
• Pregnant or suspicion of pregnancy
• Participation in an interventional or pharmaceutical clinical study if treatment/intervention has already commenced
• Previously had a hysterectomy
• Previously had pelvic cancer
• Previously had chemotherapy or pelvic radiotherapy
• Currently undergoing hormone-based treatment for breast or other cancer
• Women with known Hepatitis B, Hepatitis C, HIV or HTLV-II infection, or any other similarly classified human pathogen including prion diseases (Creutzfeldt-Jakob disease).

Sponsors & Collaborators

• Origin Sciences: lead
• Royal Infirmary of Edinburgh: collaborator

Study Sites (1)

The Queens Medical Research Institute

Edinburgh, Scotland, EH16 4TJ, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITH DNA

The hydrophilic membrane on the Oricol device allows collection of material from the wall of the vagina including vaginal mucus for analysis.

MeSH Terms

Conditions

Vaginal Diseases; Disease

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Andrew Horne, PhD MRCOG

  Edinburgh Royal Infirmary

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2023
• First Posted: February 1, 2023
• Study Start: January 11, 2024
• Primary Completion: May 30, 2024
• Study Completion: July 31, 2024
• Last Updated: October 18, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)