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

Sponsor
Ellele Health
Study ID
NCT07429799
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Ellele Sampling Device — DEVICE
    Participants will undergo vaginal fluid sampling using the Ellele balloon sampling device

Study Details

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.

Key Dates

First listed
Feb 24, 2026
Start date
Feb 5, 2026
Status verified
Feb 2026
Primary completion
Feb 6, 2027
Completion
Sep 1, 2027

Study Design

Enrollment
300 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: Ellele Sampling Device

Primary Outcome Measure

Correlation between vaginal molecular biomarker levels and clinical diagnosis of endometrial or ovarian cancer [ Time Frame: 18 months ]

Central Contacts

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Endometrial cancer trialsOvarian cancer trialsOncology trialsGynecologic oncology trialsWomen's health trials

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