Ovarian CancerNCT07429799
An Exploratory Study of Detection of Endometrial and Ovarian Cancers in Vaginal Samples Retrieved by the Ellele Sampling Device
A study testing Ellele Sampling Device in people with Ovarian Cancer and Endometrial Cancer, run by Ellele Health.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Ovarian Cancer, Endometrial Cancer
- What is being tested?
- Ellele Sampling Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- 5 Feb 2026to 1 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years old or over at time of consent for study
- Be able to give voluntary, written informed consent to participate in the study
- Attending secondary gynaecology services
- Able to tolerate a vaginal speculum examination or a tampon
Who cannot join
- Vaginal, vulval or perineal symptoms make vaginal examination inappropriate
- History of allergic reactions to polypropylene and/or nylon and/or nitrile and/or barrier contraception
- Current pregnancy or suspicion of pregnancy
- Known Hepatitis B or C, HIV, HTLV-II or any other similarly classified human pathogen including prion diseases (Creutzfeldt-Jakob disease)
- Undergone pelvic radiotherapy within the last 6 weeks
- Undergone systemic chemotherapy, immunotherapy, or received a novel pharmaceutical agent for malignancy within the last 3 weeks
- Previously undergone hysterectomy or absence of a uterus
- Clinician-determined exclusion for medical or social reasons
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read more
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.
- Conditions
- Ovarian Cancer, Endometrial Cancer
- Being tested
- Ellele Sampling Device
- Keywords
- Ovarian Cancer, Endometrial Cancer, Early detection
- Medical subject headings
- Ovarian Neoplasms, Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ellele Sampling DeviceDevice
Participants will undergo vaginal fluid sampling using the Ellele balloon sampling device
| Study group | Role | What they receive |
|---|---|---|
| Ellele Sampling Device | Experimental | Not described Receives: Device: Ellele Sampling Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 18 months
Secondary outcomes (12)
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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 18 months
Calculate enrolment metrics, including numbers of participants given a Patient information sheet, consented and retained.
Measured: 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.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2026
- Study start5 Feb 2026 (estimated)
- Primary completion6 Feb 2027 (estimated)
- Study completion1 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ellele Health
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Gateshead Health NHS Foundation Trust, Royal Infirmary of Edinburgh
- Responsible party
- Sponsor
- Investigators
- James May, Principal investigator, Royal Infirmary of Edinburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07429799
- Sponsor's protocol ID
- 349070
- Status last verified
- Feb 2026
- First submitted
- 12 Jan 2026
- Last updated
- 24 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Study of Detection of Endometrial and Ovarian Cancers in Vaginal Samples Retrieved by the Ellele Sampling Device
- ClinicalTrials.gov ID
- NCT07429799
- Acronym / sponsor ID
- 349070
- Conditions
- Ovarian Cancer, Endometrial Cancer
- Keywords
- Ovarian Cancer, Endometrial Cancer, Early detection
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Ellele HealthIndustry (pharma, biotech, devices)
- Collaborators
- Gateshead Health NHS Foundation Trust, Royal Infirmary of Edinburgh
- Study start
- 5 Feb 2026 (estimated)
- Primary completion
- 6 Feb 2027 (estimated)
- Study completion
- 1 Sep 2027 (estimated)
- First posted
- 24 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ellele Sampling Device | Experimental | Device: Ellele Sampling Device |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 years old or over at time of consent for study
- Be able to give voluntary, written informed consent to participate in the study
- Attending secondary gynaecology services
- Able to tolerate a vaginal speculum examination or a tampon
Key exclusion criteria (8 listed)
- Vaginal, vulval or perineal symptoms make vaginal examination inappropriate
- History of allergic reactions to polypropylene and/or nylon and/or nitrile and/or barrier contraception
- Current pregnancy or suspicion of pregnancy
- Known Hepatitis B or C, HIV, HTLV-II or any other similarly classified human pathogen including prion diseases (Creutzfeldt-Jakob disease)
- Undergone pelvic radiotherapy within the last 6 weeks
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ellele Sampling DeviceParticipants will undergo vaginal fluid sampling using the Ellele balloon sampling device | Device | Ellele Sampling Device |
Primary outcome
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.
12 secondary outcomes
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
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
Vaginal genomic biomarker variant allele frequency measured from samples collected using the Ellele Sampling Device
Time frame: 18 months
Vaginal DNA methylation percentage at predefined CpG loci measured from samples collected using the Ellele Sampling Device
Time frame: 18 months
Vaginal transcriptomic biomarker expression levels measured from samples collected using the Ellele Sampling Device
Time frame: 18 months
Vaginal proteomic biomarker concentration or relative abundance measured from samples collected using the Ellele Sampling Device
Time frame: 18 months
Vaginal microbiome relative abundance and diversity indices measured from samples collected using the Ellele Sampling Device
Time frame: 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
Correlation between vaginal sample quality metrics and participant clinical characteristics
Time frame: 18 months
Correlation between vaginal sample quality metrics and sample collection and processing time variables
Time frame: 18 months
Calculate enrolment metrics, including numbers of participants given a Patient information sheet, consented and retained.
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
James May principal investigator
Royal Infirmary of Edinburgh
Questions about this trial
What is this clinical trial studying?
A study testing Ellele Sampling Device in people with Ovarian Cancer and Endometrial Cancer, run by Ellele Health.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nagulendram (0131 536 1000, ovia.nagulendram@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between vaginal molecular biomarker levels and clinical diagnosis of endometrial or ovarian cancer (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2026; AzTrials last refreshed its copy on 26 Oct 2026.