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

February 17, 2026 updated by: Ellele Health

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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
300

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Correlation between vaginal molecular biomarker levels and clinical diagnosis of endometrial or ovarian cancer
Time Frame: 18 months
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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
Time Frame: 18 months
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.
Time Frame: 18 months
18 months
Vaginal genomic biomarker variant allele frequency measured from samples collected using the Ellele Sampling Device
Time Frame: 18 months
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
Time Frame: 18 months
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
Time Frame: 18 months
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
Time Frame: 18 months
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
Time Frame: 18 months
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.
Time Frame: 18 months
18 months
Correlation between vaginal sample quality metrics and participant clinical characteristics
Time Frame: 18 months
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
Time Frame: 18 months
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.
Time Frame: 18 months
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).
Time Frame: 18 months
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ellele Health

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Royal Infirmary of Edinburgh
Gateshead Health NHS Foundation Trust

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: James May, Royal Infirmary of Edinburgh

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 5, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 6, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 12, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 17, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 24, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 24, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 17, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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