Reproductive health Pregnancy and Childbirth
Conditions
Interventions
All participants would be enrolled into one group and will have the device implanted for 7 days only between days 14-21 of their menstrual cycle. The device will monitor uterine temperature and dissol
Sponsors
Verso Biosense Limited
Eligibility
Sex/Gender
Female
Age
18 Years to 42 Years
Inclusion criteria
Inclusion criteria: 1. Women with regular menstrual cycles of approximate even duration e.g between 21-35 days 2. Women who are at least 18 years of age and less than or equal to 42 years of age 3. Clinically suitable for insertion of an intra-uterine device in an outpatient setting 4. No chronic illness e.g. diabetes, autoimmune disorders 5. Patient able to comprehend and sign the Informed Consent prior to enrolment in the study 6. BMI range 20 to 27 7. Able and willing to use barrier contraception (male condoms) or abstain from sexual intercourse during the menstrual cycle of the trial period
Exclusion criteria
Exclusion criteria: 1. Pregnant, breastfeeding or planning a pregnancy during the course of the trial. 2. Pregnancies within the previous 3 months 3. Using hormonal contraception/therapies 4. History of miscarriage 5. Birth abnormalities or complications from previous pregnancies 6. Uterine anatomical abnormalities which, in the opinion of the investigator, may complicate the placement and removal of the device. 7. Concomitant medical treatment for or has any significant disease or disorder which, in the opinion of the investigator, may put the participants at risk. 8. Known allergies to local anaesthetics, silicone and barium sulphate (both are components of the device) 9. Undergoing investigation for abnormal uterine bleeding. 10. Current pelvic inflammatory disease, cervicitis, current genital infection, conditions associated with increased susceptibility to infections, cervical dysplasia, uterine or cervical malignancy. 11. Concurrent use of body-worn medical electronic devices. 12. No pre-existing or historical conditions which may impact the outcomes of this study (e.g abnormal cx smear) 13. Planned overseas travel for the duration of the study 14. Unable to comply with the study protocol 15. Require X-rays or other medical scans for the duration of the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Intrauterine dissolved oxygen levels and intrauterine temperature measured using data collected from the IRIS device over 7 days in healthy volunteer females with normal menstrual cycles. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Device safety will be assessed using the following variables: 1.1. Number and occurrence of known clinical risks measured using clinical observation and reporting at study completion 1.2. Adverse events measured using participant reports and clinical records at study completion 1.3. Analgesic consumption measured using data collected in a patient diary across seven days post-procedure 2. Device user acceptance will be assessed using the following variables: 2.1. Tolerance of device use measured using a patient diary across seven days post-procedure 2.2. Frequency of study withdrawal and completion measured using participant tracking at study completion 2.3. User experience measured using a patient questionnaire at a 3-day follow-up | — |
Countries
England, Scotland, United Kingdom
Contacts
Public ContactMariea Parvaz
Outcome results
None listed