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Ellele-01: Feasability study

Study summary: A single-site, prospective feasibility study conducted at the Royal Infirmary of Edinburgh, Edinburgh, Scotland, UK, between January and July 2024

Study objective: Assess the feasibility of collecting vaginal samples using the Ellele Sampling Device

Participants: 45 women undergoing a speculum exam

Key findings

Patient Preferred Sampling Method

  • All participants subjected to dual sampling preferred the Ellele Sampling Device, citing greater comfort (61%)

Clinician Preferred Sampling Method

  • In 95% of the exams, clinicians preferred the Ellele Sampling Device to the speculum citing ease of use and positive patient feedback

Human and Microbial DNA Recovery

  • Sample was dissolved in up to 4 ml of buffer, enabling extraction of both human and microbial DNA
  • Up to 66 µg of total DNA (>90% with DIN>8) was extracted per sample, ~26x more DNA than from a swab [1]

Compatibility with advanced multiomics analyses

  • Sample collected is compatible with mutation, methylation and whole-genome sequencing of host and microbial DNA
  • Microbial profiles were consistent with established literature, demonstrating a representative sample of the vaginal microbiome

Publications

You can read more about Ellele-01 study here.

References

  1.       Ellele data on file [indirect, literature-based comparison].

Elelle-02: Exploratory study in endometrial and ovarian cancers (NCT07429799)

Study summary: A prospective exploratory study conducted across two sites, the Royal Infirmary of Edinburgh and Queen Elizabeth Hospital, Gateshead, commencing in 2026.

Participants: Controlled endometrial cancer cohort (100 participants), controlled ovarian cancer cohort (100 participants), R&D cohort (50 participants)

Key objectives

Identify endometrial and ovarian cancer biomarkers

  • Determine the ability to stratify controls from endometrial and ovarian cancer cases using samples collected with the Ellele Device

Validate patient acceptability

  • Measure patient acceptability and comfort using a standard discomfort scale following use of the Ellele Sampling Device

Investigate DNA extraction and processing

  • Investigate DNA sample quality and quantity, validate DNA processing methodology and assess multiomics pipeline on vaginal mucus samples and across different disease cohorts

Understand concordance between sample types

  • Compare vaginal samples with matched clinical specimens including blood, urine, ascitic fluid, or tumour tissue where available, to understand concordance across sample types

Publications

You can read more about Ellele-02 here.

Ellele-03: Validation Study

Study summary: Ellele-03 validation study is planned as a follow-up study to Ellele-02, aimed at validating both a novel clinical pathway for women with postmenopausal bleeding, and novel biomarkers identified using the Ellele Sampling Device.