New breath diagnostics to improve management of HOA
Research type
Research Study
Full title
Clinical evaluation of the performance of a breath ammonia measurement device for its ability to measure levels of systemic ammonia
IRAS ID
201285
Contact name
Suresh Vijay
Contact email
Sponsor organisation
BreathDX (UK) Ltd
Duration of Study in the UK
0 years, 5 months, 30 days
Research summary
A range of disorders result in abnormally elevated levels of ammonia, which has serious health implications. Current assessment and testing for elevated ammonia is challenging and can be significantly improved. A device exists which can measure ammonia in breath. However, it is not yet known if this correlates effectively with levels of ammonia in blood. A clinical evaluation of the device will be performed on a group of participants with normal ammonia levels and participants with elevated ammonia levels caused by organic acidaemias. The relationship between breath and blood ammonia levels will be analysed to see if it is possible to predict ammonia levels using breath.
REC name
Wales REC 6
REC reference
16/WA/0371
Date of REC Opinion
19 Dec 2016
REC opinion
Unfavourable Opinion