Ellele-01: Feasbility Study Launch Announcement

Ellele Sampling Device is a novel vaginal sampling device designed to collect a richer and more representative vaginal sample, while preserving the comfort of patients. Origin Sciences has launched Ellele-01, the first clinical research study evaluating the Ellele Sampling Device, marking an important milestone in the development of the technology.

Ellele-01 is a single-site, prospective feasibility study being conducted at the Royal Infirmary of Edinburgh. The study is designed to assess the feasibility of collecting vaginal samples using the Ellele Sampling Device in women undergoing a speculum examination, while evaluating both patient and clinician experience.

Key objectives of the study include assessing patient acceptability and clinician usability, alongside the ability to recover high-quality biological material from a single vaginal sample. Ellele-01 will explore whether samples collected with the Ellele Sampling Device are suitable for downstream molecular analyses relevant to gynaecological research and early disease detection.

The study will evaluate the recovery of both human and microbial DNA from each sample, with a focus on DNA quality and quantity. Extracted material will be assessed for compatibility with advanced multi-omics analyses, including mutation and methylation analysis of host DNA and whole-genome shotgun sequencing of microbial DNA.

The launch of Ellele-01 represents a foundational step in Ellele Health’s clinical development programme, generating early evidence to support the future use of minimally invasive sampling technologies in women’s health research and care.