Ellele-01
Research type
Research Study
Full title
Feasibility Study to Investigate the Use of the Ellele Sampling Device Kit to Retrieve Vagina Mucus Samples for Genomic & Epigenetic Analysis.
IRAS ID
323272
Contact name
Andrew Horne
Contact email
Sponsor organisation
Origin Sciences Ltd
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 6 months, 4 days
Research summary
Summary of Research
This is a feasibility study to Investigate the Use of the OriCol™ Sampling Device to Retrieve Vagina Mucus Samples for Genomic & Epigenetic Analysis.Previous tests and studies using the OriCol™ Sampling Device have been conducted but this has been to collect a sample of mucus from the back passage (rectum) to detect bowel diseases including cancer. As the mucus in the rectum and vagina are similar, this study is to see if it is possible to collect a mucus sample from the vagina, which can potentially be used to diagnose problems of the female genital tract. In addition to this, feedback from the participant and clinician on the acceptability of using the Sampling Device in comparison to a standard speculum examination will be collected.
The OriCol™ Sampling Device will be used in this study outside the purpose for which it is intended, (collection of rectal mucus) and will be used to collect a sample from the vaginal wall. The Sampling Device used for this study will form as part of a kit and the kit will have a new reference number, which will be clearly printed on the labelling and Instructions for Use, as Ellele Sampling Device Kit REF: PS0050.
The aim of the study is to find out if a sample from the wall of the vagina can be collected using a new piece of equipment, the Ellele Sampling Device Kit when compared to the standard test, which at the moment uses a speculum. The OriCol™ Sampling Device uses an inflated balloon to touch the surface of the vaginal wall to collect a sample of mucus.
It is planned to collect samples from 45 participants at a single UK site; Royal Infirmary EdinburghSummary of Results
Feasibility Study to Investigate the Use of the Ellele Sampling Device Kit Dear On behalf of The University of Edinburgh, The Royal Infirmary of Edinburgh, and Origin Sciences Ltd (sponsors of the Ellele Sampling Device study), we would like to thank you very much for your recent participation and valuable contribution to this study.
As you may recall from the information given to you, the aim of the study was to find out:
· if the new Ellele device was comfortable for patients
· whether it was an easy device for doctors/nurses to use
· to see if the samples obtained gave enough cells needed to investigate gynaecological problems
We are very pleased to be able to inform you that, 100% of the women participating in the study selected the Ellele Sampling Device as their preferred device compared to a speculum and the clinicians who took the samples found the device very easy to use. The scientific analysis of the samples collected; has shown they are suitable for further research to detect gynaecological problems.
Based on the positive feedback and initial analysis of the Ellele Sampling Device, Origin Sciences Ltd in collaboration with The University of Edinburgh and The Royal Infirmary of Edinburgh are already working on the next phase of research for the detection and diagnosis of gynaecological problems.
It is because of you and patients like you, who very kindly participate in medical research studies, that we can make a difference to the progress of medical treatment and early detection of diseases to help our future generations.
We thank you once again for your participation.
With kind regards and best wishes for the future.
The University of Edinburgh, The Royal Infirmary of Edinburgh, Origin Sciences LtdREC name
South East Scotland REC 02
REC reference
23/SS/0046
Date of REC Opinion
2 Aug 2023
REC opinion
Further Information Favourable Opinion