Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:18 AM
Ignite Modification Date:
2025-12-25 @ 3:18 AM
NCT ID:
NCT04397705
Eligibility Criteria:
Inclusion Criteria:
1. Participants are capable of giving informed consent
2. Male or female aged 18 or over
3. Diagnosis of any solid tumour or haematological malignancy meeting one of the following criteria:
* Current malignant diagnosis
* Received anti-cancer treatment within the last two years
4. Emergency presentation to hospital with symptoms consistent with Covid-19 deemed to meet the criteria for Covid-19 testing by admitting clinician.
5. Deemed by the admitting clinician to be suitable for outpatient management of suspected Covid-19.
6. Stable oxygen saturations of 95% or higher at time of emergency presentation.
7. Able to complete tolerability questionnaire.
8. Able and willing to comply with twice daily pulse oximetry monitoring as outlined in section 6 of the protocol.
9. ECOG-PS \<4
10. Life expectancy of greater than three months as assessed by screening investigator from review of electronic patient record.
Exclusion Criteria:
1. Patients hospitalized for more than 24 hours at initial presentation with symptoms consistent with Covid-19.
2. Pregnant patients.
3. Patients unable to give informed consent.
4. Presence of ulceration or pre-existing skin rash at site of device application (left precordium and axillae). If only one axilla affected this is not an exclusion criterion if patient is happy to apply temperature sensor to the other axilla.
5. Radiotherapy to the left chest wall either during or within the six months preceding the study. Plans for subsequent radiotherapy to commence after study completion are not an exclusion criterion. If only one axilla is within the planned radiotherapy field and patient is happy to apply temperature sensor to the other axilla this is not an exclusion criteria.
6. History of allergy or contact dermatitis to medical adhesives e.g sticking plasters, ECG electrodes.
7. Patients with pacemakers, implantable defibrillators or neurostimulators.
8. Patients who are currently receiving treatment as part of a clinical study or have had their end of treatment visit for another clinical study less than 30 days prior to the study enrollment visit.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04397705
Study Brief:
Protocol Section:
NCT04397705