An Exploratory Study of Detection of Endometrial and Ovarian Cancers in Vaginal Samples Retrieved by the Ellele Sampling Device

An exploratory study of early detection and investigation of gynaecological diseases

Throughout a woman's life, she may need tests that can feel uncomfortable, such as a smear test or a biopsy taken through the vagina. These tests are important for diagnosing and monitoring women's health. Detecting gynaecological cancers - like ovarian and endometrial cancer - can be difficult because symptoms are often vague, and current tests can be invasive and may require multiple hospital visits.

Ellele Health has developed a new medical device called the Ellele Sampling Device. This device is designed to gently collect a sample from the vaginal wall. Early studies have shown it can collect enough cells for laboratory analysis, with the potential to detect gynaecological conditions in a way that is less invasive and more comfortable than existing tests.

In this study, the investigators will use the Ellele Device to collect samples from both cancer patients and patients considered to be comparative controls. Taking part does not mean the patient has cancer or that the patient is being tested for cancer. The sample will only be used for research. The aim is to see whether this new device can pick up biological markers linked to endometrial and ovarian cancer and to assess how easy it is to use in a clinical setting. The findings could help improve early detection and reduce the need for more invasive procedures in the future.

Study Overview

• Status: Not yet recruiting
• Conditions: Ovarian Cancer; Endometrial Cancer
• Intervention / Treatment: Device: Ellele Sampling Device

• Study Type: Interventional
• Enrollment (Estimated): 300
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nagulendram; Phone Number: 0131 536 1000; Email: ovia.nagulendram@nhs.net
• Study Contact Backup: Name: Neil Ryan; Phone Number: 0131 536 1000; Email: neilryan@nhs.net

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. 18 years old or over at time of consent for study
2. Be able to give voluntary, written informed consent to participate in the study
3. Attending secondary gynaecology services
4. Able to tolerate a vaginal speculum examination or a tampon

Exclusion Criteria:

1. Vaginal, vulval or perineal symptoms make vaginal examination inappropriate
2. History of allergic reactions to polypropylene and/or nylon and/or nitrile and/or barrier contraception
3. Current pregnancy or suspicion of pregnancy
4. Known Hepatitis B or C, HIV, HTLV-II or any other similarly classified human pathogen including prion diseases (Creutzfeldt-Jakob disease)
5. Undergone pelvic radiotherapy within the last 6 weeks
6. Undergone systemic chemotherapy, immunotherapy, or received a novel pharmaceutical agent for malignancy within the last 3 weeks
7. Previously undergone hysterectomy or absence of a uterus
8. Clinician-determined exclusion for medical or social reasons

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ellele Sampling Device	Device: Ellele Sampling Device; Participants will undergo vaginal fluid sampling using the Ellele balloon sampling device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation between vaginal molecular biomarker levels and clinical diagnosis of endometrial or ovarian cancer	For each participant, predefined molecular biomarkers will be measured from vaginal samples collected using the Ellele Sampling Device. Biomarkers will be assessed quantitatively, including normalised read counts or variant allele frequency for genomic and transcriptomic biomarkers, methylation percentage at selected CpG loci for epigenomic biomarkers, protein concentration or relative abundance for proteomic biomarkers, and relative microbial abundance (%) and diversity indices for microbiome biomarkers. Correlations between biomarker measures and clinical diagnosis of endometrial or ovarian cancer will be evaluated.	18 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Calculate DNA extraction QC pass/failure rates, as defined in Ellele-01, to verify technology compatibility across disease cohorts (e.g. ovarian cancer, endometrial cancer) and participants where no cancer has been identified		18 months
By using laboratory and data QC metrics for each 'omic assessed (e.g transcriptomics, methylation analysis etc) to calculate pass/failure rates, for assessment of technology compatibility.		18 months
Vaginal genomic biomarker variant allele frequency measured from samples collected using the Ellele Sampling Device	Genomic biomarkers will be measured from vaginal samples collected using the Ellele Sampling Device using sequencing-based assays. Outcomes will be reported as variant allele frequency (VAF) for predefined cancer-associated variants.	18 months
Vaginal DNA methylation percentage at predefined CpG loci measured from samples collected using the Ellele Sampling Device	Epigenomic biomarkers will be measured from vaginal samples collected using the Ellele Sampling Device using DNA methylation assays. Outcomes will be reported as methylation percentage (%) at predefined CpG loci.	18 months
Vaginal transcriptomic biomarker expression levels measured from samples collected using the Ellele Sampling Device	Transcriptomic biomarkers will be measured from vaginal samples collected using the Ellele Sampling Device using RNA sequencing-based assays. Outcomes will be reported as normalised gene expression values for predefined transcriptomic biomarkers.	18 months
Vaginal proteomic biomarker concentration or relative abundance measured from samples collected using the Ellele Sampling Device	Proteomic biomarkers will be measured from vaginal samples collected using the Ellele Sampling Device using proteomic assays (e.g., multiplex protein panels or mass spectrometry-based methods). Outcomes will be reported as protein concentration (e.g., ng/mL) or relative abundance for predefined protein biomarkers.	18 months
Vaginal microbiome relative abundance and diversity indices measured from samples collected using the Ellele Sampling Device	Microbiome biomarkers will be measured from vaginal samples collected using the Ellele Sampling Device using sequencing-based microbiome profiling methods. Outcomes will be reported as relative microbial abundance (%) of predefined taxa and microbiome diversity indices (e.g. Shannon diversity index).	18 months
Use pairwise concordance analysis of 'omic signatures between vaginal mucus samples and appropriate available matched samples (e.g. ascitic fluid, tumour blocks) where feasible.		18 months
Correlation between vaginal sample quality metrics and participant clinical characteristics	Sample quality metrics will be assessed for vaginal samples collected using the Ellele Sampling Device. Sample quality measures will include total nucleic acid yield (ng), nucleic acid integrity metrics (e.g., RNA integrity number or DNA fragment size), and sequencing library quality metrics (e.g., read depth and mapping rate). Clinical characteristics will include participant age (years), body mass index (BMI, kg/m²), and disease stage as recorded in the medical record. Correlations between sample quality metrics and clinical characteristics will be evaluated.	18 months
Correlation between vaginal sample quality metrics and sample collection and processing time variables	Sample quality metrics will be assessed for vaginal samples collected using the Ellele Sampling Device. Sample quality measures will include total nucleic acid yield (ng), nucleic acid integrity metrics (e.g., RNA integrity number or DNA fragment size), and sequencing library quality metrics (e.g., read depth and mapping rate). Logistical variables will include time from sample collection to laboratory processing (hours) and time of day of sample collection (clock time). Correlations between sample quality metrics and logistical variables will be evaluated.	18 months
Calculate enrolment metrics, including numbers of participants given a Patient information sheet, consented and retained.		18 months
Acceptability of the Ellele Sampling Device measured using a Visual Analogue Scale measured after use (only on patients who are not undergoing the procedure during surgery).	Acceptability of the Ellele Sampling Device will be assessed in participants who are not undergoing the sampling procedure during surgery. Acceptability will be measured using a Visual Analogue Scale (VAS) ranging from 0 to 10, where 0 indicates "not painful at all" and 10 indicates "worst pain imaginable." Higher scores indicate greater pain associated with use of the device. The VAS will be completed by participants immediately after use of the device.	18 months

Collaborators and Investigators

• Sponsor: Ellele Health
• Collaborators: Royal Infirmary of Edinburgh; Gateshead Health NHS Foundation Trust
• Investigators: Principal Investigator: James May, Royal Infirmary of Edinburgh

Study record dates

Study Major Dates

• Study Start (Estimated): February 5, 2026
• Primary Completion (Estimated): February 6, 2027
• Study Completion (Estimated): September 1, 2027

Study Registration Dates

• First Submitted: January 12, 2026
• First Submitted That Met QC Criteria: February 17, 2026
• First Posted (Actual): February 24, 2026

Study Record Updates

• Last Update Posted (Actual): February 24, 2026
• Last Update Submitted That Met QC Criteria: February 17, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Ovarian Cancer; Endometrial Cancer; Early detection
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Endocrine System Diseases; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Uterine Diseases; Genital Diseases, Female; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Neoplasms, Female; Gonadal Disorders; Uterine Neoplasms; Ovarian Neoplasms; Endometrial Neoplasms
• Other Study ID Numbers: 349070

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No