Feasibility of the Oricol™ Sampling Device to Retrieve Vagina Mucus (Wall) Samples for Genomic & Epigenetic Analysis. (Ellele-01)
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ClinicalTrials.gov Identifier: NCT05709119 |
Recruitment Status :
Recruiting
First Posted : February 1, 2023
Last Update Posted : January 19, 2024
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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:
- Acceptability of the sampling technique to both patient and clinician
- To 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 Scale
- Patient discrete choice of Oricol™ versus speculum examination.
Condition or disease | Intervention/treatment |
---|---|
Vagina Disease Diagnosis | Diagnostic Test: Quantification of human DNA retrieved and DNA fragmentation profile. |
Study Type : | Observational [Patient Registry] |
Estimated Enrollment : | 45 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Target Follow-Up Duration: | 1 Day |
Official Title: | Feasibility Study to Investigate the Use of the Oricol™ Sampling Device to Retrieve Vagina Mucus (Wall) Samples for Genomic & Epigenetic Analysis. |
Actual Study Start Date : | January 13, 2024 |
Estimated Primary Completion Date : | June 30, 2024 |
Estimated Study Completion Date : | December 31, 2024 |
- Diagnostic Test: Quantification of human DNA retrieved and DNA fragmentation profile.
The sample will be analysed for material quality and have no impact on the patient's future care.
- The primary objective is to explore the feasibility of collecting an assessable vaginal sample using the OriCol™ Sampling Device. [ Time Frame: Within 3 months of completion of recruitment ]Quantification of human DNA retrieved.
- Acceptability of the sampling technique to both patient and clinician [ Time Frame: Immediate from test performance ]To assess both ease of use and patient acceptance
- To understand the balloon volume (maximum 80ml) required for effective intra-vaginal sampling. [ Time Frame: Within 3 months ]Assess variation of vaginal volume and balloon inflation to sample retrieved.
- Participant feedback during and after the test for using the OriCol™ Sampling Device using a Visual Analogue Scale [ Time Frame: Immediate from test performance ]To assess patient feedback from the test compared to the speculum examination
Biospecimen Retention: Samples With DNA
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Ages Eligible for Study: | 18 Years to 99 Years (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Gender Based Eligibility: | Yes |
Gender Eligibility Description: | As an intravaginal examination technique, the presence of a natural vagina is required. |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria: All participants must meet the following criteria to be eligible for the study:
- 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
Exclusion Criteria: The following exclusion criteria are applied
- 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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05709119
Contact: Ian R Daniels, FRCS | +44 (0)1223 750490 | ian.daniels@orginsciences.com | |
Contact: Megan Sands, BDes | +44 (0)1223 750490 | megan.sands@originsciences.com |
United Kingdom | |
The Queens Medical Research Institute | Recruiting |
Edinburgh, Scotland, United Kingdom, EH16 4TJ | |
Contact: Neil Ryan, PhDMRCSMRCOG +447834805213 neilryan@nhs.net |
Principal Investigator: | Andrew Horne, PhD MRCOG | Edinburgh Royal Infirmary |
Responsible Party: | Origin Sciences |
ClinicalTrials.gov Identifier: | NCT05709119 |
Other Study ID Numbers: |
Ellele-01 |
First Posted: | February 1, 2023 Key Record Dates |
Last Update Posted: | January 19, 2024 |
Last Verified: | January 2024 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Vaginal Diseases Genital Diseases, Female Female Urogenital Diseases |
Female Urogenital Diseases and Pregnancy Complications Urogenital Diseases Genital Diseases |