Capillary blood sampling in adults Circulatory System
Conditions
Interventions
This is a non-randomised, single-centre study for investigation of gentleheel®, a lancet device that is already CE marked and FDA approved for capillary blood sampling from the heels of neonates.
paediatric haematology (volume 0.5mL) and biochemistry (volume 0.6mL) from a single fingertip puncture, while assessing the user's perception of pain from using the device, and investigate any subsequ
Sponsors
Mowgli Innovation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subjects older than 18 years (adults). 2. Subjects able to provide informed consent.
Exclusion criteria
Exclusion criteria: 1. Subjects younger than 18 years. 2. Subjects unable to provide informed consent. 3. Subjects who may be dehydrated. 4. Subjects diagnosed with poor peripheral circulation from other causes. 5. Subjects who present with a callus, skin ulceration, or blister at the intended puncture site. 6. Subjects with thrombocytopenia and/or Platelet abnormalities. 7. Subjects diagnosed with peripheral edema. Pregnancy or breastfeeding (self-reported). 8. Confirmed or suspected malignant cancer. 9. Anxiety with needles or finger pricks. 10. History of blood borne infection (e.g., HIV, hepatitis B or C, syphilis, malaria, babesiosis, brucellosis, leptospirosis, arboviral infections, relapsing fever, T lymphotropic virus Type 1, Creutzfeldt-Jakob disease). 11. Currently participating in another study. 12. Donation or loss of 400 mL or more of blood within 4 weeks prior to the start of the study. 13. Any other condition that in the Investigator opinion may negatively influence Subject's participation in the study. 14. Intake of medicines that affect blood coagulability (including anticoagulants such as vitamin K, antivirals and anticoagulants such as heparin, aspirin, thrombin inhibitors, vitamin K antagonists).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Volume of blood collected (ml) measured after the procedure | — |
Secondary
| Measure | Time frame |
|---|---|
| Pain measured using the Numerical Pain Rating Scale after the procedure | — |
Countries
England, United Kingdom
Contacts
Public ContactGeorges Haines
Outcome results
None listed