NCT07429799Not yet recruiting
An Exploratory Study of Detection of Endometrial and Ovarian Cancers in Vaginal Samples Retrieved by the Ellele Sampling Device
Source: ClinicalTrials.gov · Last updated 24 Feb 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 300 (estimated)
- First submitted
- 12 Jan 2026
- Start date
- 5 Feb 2026
- Primary completion date
- 6 Feb 2027
- Lead sponsor
- Ellele Health
- Diseases
- Endometrial cancer, Ovarian cancer
- NCT number
- NCT07429799
What you commit to
- Study type: Interventional
- Planned participants: 300
- From 5 Feb 2026 to the primary completion date, 6 Feb 2027
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- History of allergic reactions to polypropylene and/or nylon and/or nitrile and/or barrier contraception
- Known Hepatitis B or C, HIV, HTLV-II or any other similarly classified human pathogen including prion diseases (Creutzfeldt-Jakob disease)
Other
- Vaginal, vulval or perineal symptoms make vaginal examination inappropriate
- Current pregnancy or suspicion of pregnancy
- Clinician-determined exclusion for medical or social reasons
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: Female · Accepts healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.