Monitoring of the Intrauterine environment (Mini-I)
Research type
Research Study
Full title
Miniaturised Intrauterine sensing device: understanding the in vivo uterine environment – a feasibility study
IRAS ID
150746
Contact name
Ying Cheong
Contact email
Sponsor organisation
University Hospital Southampton NHS Foundation Trust
Research summary
The purpose of this study is to evaluate the practical aspects of a small sensor device, which can detect temperature when placed within a woman’s womb. Currently very little is known about the environment of the inside of the womb, including temperature. Our team from the University of Southampton has the last few years developed a small sensor device which can placed inside the womb, with no wires or batteries with the intention to help researchers understand the uterine environment better. Our team is also planning to build on other sensors onto this device to detect oxygen, chemical, hormones which can potentially inform doctors of abnormalities within the womb which can affect a women’s health e.g. having a baby. The device has undergone testing in rabbits and has been shown to be functioning well. We are now hoping to evaluate its usefulness in humans. It involves the recruitment of 15 healthy women aged between 18-45 years who are attending theatre for a hysteroscopy (internal inspection of the womb with a camera) and will be conducted at the Princess Anne Hospital, Southampton for a maximum of 6 months. The device will be placed inside the womb when the patient is asleep under anaesthesia when they are having their operation for a duration of a few hours to 3 days. At the end of the study period, the device will be removed through a speculum (like a smear test) with no anaesthetics required. The practicalities of insertion and removal, as well as the data received during this feasibility study will be analysed, with the view to conduct a further studies in the future.
REC name
HSC REC B
REC reference
14/NI/1031
Date of REC Opinion
15 Sep 2014
REC opinion
Further Information Favourable Opinion