Evaluation of GRI gentleheel® incision device for adult blood sampling
Research type
Research Study
Full title
Evaluation of the GRI gentleheel® incision device for adult fingertip blood sampling - intended use extension
IRAS ID
311621
Contact name
Georges-Alexandre Haines
Contact email
ISRCTN Number
ISRCTN48548060
Duration of Study in the UK
0 years, 4 months, 31 days
Research summary
Blood tests are one of the most routinely carried out procedures in healthcare. Until recently, this involved using a needle to puncture a vein, known as venepuncture. Venepuncture carries potential risks of pain, bruising, sharp injury and anaemia associated with repeat tests. It also requires a specially trained professional to undertake the procedure. An alternative to this is capillary blood testing. This involves the use of a micro-lancet to make a small 1-2mm puncture in the fingertip resulting in pin-point bleeding. This blood can then be used for analysis in the same way as venepuncture-obtained blood. This technology is well established in paediatric medicine and diabetics use micro-lancets routinely to test blood sugar levels. Capillary blood sampling has the advantage of being less painful, requires fewer consumables, may not require a trained professional and causes less anxiety for the patient. However one disadvantage is obtaining sufficient blood volume when testing a larger number of blood analytes.
gentleheel® is a lancet-based device already used by healthcare professionals to obtain blood from the heels of new-borns and has been used in millions of patients for over a decade. The advantage of gentleheel® is its ability to draw more blood than other lancet-based devices.
We want to investigate whether gentleheel® can also be used by adult lay members of the public themselves, without needing a healthcare professional, to obtain blood from their fingertips. We will measure the volume of blood collected and any associated pain from the procedure.
We will be recruiting 50 healthy adults for this purpose, using gentleheel® to draw blood from the middle and ring fingertips, with the study taking place in a supervised clinical environment. The study will take 20-30 minutes per participant. If proved successful, this device will be of great benefit as an alternative for collecting blood.
REC name
HSC REC A
REC reference
22/NI/0063
Date of REC Opinion
10 May 2022
REC opinion
Further Information Favourable Opinion