Ignite Creation Date:
2025-12-25 @ 4:04 AM
Ignite Modification Date:
2025-12-26 @ 2:59 AM
Study NCT ID:
NCT04914702
Status:
COMPLETED
Last Update Posted:
2022-07-11
First Post:
2021-06-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Feasibility and Comparison of Continuously Monitored Vital Signs in Pediatric Patients With Cancer.
Sponsor:
Insel Gruppe AG, University Hospital Bern
Organization:
Study Overview
Official Title:
Continuous Monitoring of Vital Signs With Different Wearable Devices in Pediatric Patients Undergoing Chemotherapy for Cancer - a Comparison and Feasibility Pilot Study
Status:
COMPLETED
Status Verified Date:
2022-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
In this pilot study the feasibility continous recording of vital signs in pediatric patients under chemotherapy for cancer, is studied.
Vital signs and are recorded with two different wearable devices (WDs): Everion®, by Biovotion (now Biofourmis), Zurich, Switzerland and CORE® by GreenTEG, Zurich, Switzerland. Patients can choose if they want to wear one or both WDs during this study. Those opting to wear two WDs can choose if they want to wear them in parallel, or sequentially.
Results from the two different WDs will be compared. Study duration for each participant is 14 days per device.
Vital signs and are recorded with two different wearable devices (WDs): Everion®, by Biovotion (now Biofourmis), Zurich, Switzerland and CORE® by GreenTEG, Zurich, Switzerland. Patients can choose if they want to wear one or both WDs during this study. Those opting to wear two WDs can choose if they want to wear them in parallel, or sequentially.
Results from the two different WDs will be compared. Study duration for each participant is 14 days per device.
Detailed Description:
In a previous study (Bern 2019 WD Pilot, NcT04134429) the investigators found that continuous recording of vital signs with the Everion® is feasible in good quality across a wide age range (3 to 16 years) of pediatric patients undergoing chemotherapy for cancer. However, the pre-defined criterion to claim feasibility was not formally reached and low compliance was the main reason identified.
In this study the investigators want to assess the impact of measures aiming to increase compliance on feasibility for the Everion®.
Second, the investigators want to assess the feasibility of a second device, made commercially available only in October 2020, the CORE® WD by GreenTEG. Results from the two different wearable devices will be compared. Study duration for each participant is 14 days per device.
In this study the investigators want to assess the impact of measures aiming to increase compliance on feasibility for the Everion®.
Second, the investigators want to assess the feasibility of a second device, made commercially available only in October 2020, the CORE® WD by GreenTEG. Results from the two different wearable devices will be compared. Study duration for each participant is 14 days per device.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: