Ignite Creation Date:
2024-05-06 @ 6:44 PM
Last Modification Date:
2024-10-26 @ 2:53 PM
Study NCT ID:
NCT05760638
Status:
COMPLETED
Last Update Posted:
2023-04-13
First Post:
2023-02-26
Brief Title:
Real-World Evidence RWE Data Analysis of 1-year Consecutive Use of Remote Electrical Neuromodulation REN
Sponsor:
Theranica
Organization:
Theranica
Study Overview
Official Title:
Real-World Evidence RWE Data Analysis of 1-year Safety Consistent Utilization and Consistent Efficacy of Remote Electrical Neuromodulation REN
Status:
COMPLETED
Status Verified Date:
2023-02
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:
This is a Post-marketing study investigating the long-term safety utilization and efficacy of REN during 12 consecutive months of using Nerivio in migraine patients
Safety will be assessed by the number and type of adverse events Utilization will be measured by the number of monthly treatments Efficacy will be evaluated as a change in headache pain severity and functional disability from baseline to 2 hours post-treatment in at least 50 of the treatments
Safety will be assessed by the number and type of adverse events Utilization will be measured by the number of monthly treatments Efficacy will be evaluated as a change in headache pain severity and functional disability from baseline to 2 hours post-treatment in at least 50 of the treatments
Detailed Description:
The REN device Nerivio by Theranica ISRAEL is a neuromodulation device approved by the FDA for acute andor preventive treatment of migraine in patients 12 years old and above It is a wearable device applied to the upper arm It stimulates C and Aδ noxious fibers using a modulated symmetrical biphasic square pulse with a pulse width of 400 μs modulated frequency of 100-120 Hz and up to 40 mA output current which the patient can adjust The REN device is operated by a designated app that is downloaded to the users phone prior first use of the Nerivio device
As part of the sign-up process for the Nerivio app all patients accept the terms of use which specifies that providing personal information is done on their own free will and that their de-identified data may be used for research purposes Users are not obligated to provide personal information and could treat without providing any feedback The app includes a secured personal migraine diary which enables patients to record and track their migraines and other headaches At the beginning of each treatment and again 2 hours after the start of treatment patients are prompted to record their symptoms including pain level none mild moderate severe functional disability None Mild limitation Moderate limitation Severe limitation and an indication of which medications if any were taken within that 2-hour time window
Post-marketing surveillance is designed to assess the safety utilization and efficacy in larger and more diverse populations and in various real-world environments and situations As a digital therapeutic device ie electroceutical the REN device enables prospective collection of electronic patient-reported outcomes in real-world clinical practice
This post-marketing RWE study investigates the safety and efficacy of the Nerivio treatment by analyzing data of patients who used the Nerivio device for consecutive 12 months 1 year the following outcome will be assessed
1 - Safety - all adverse events that were reported within the studys period
2 - Utilization - the number of Nerivio treatments per month
3 - Efficacy - pain relief freedom from pain improvement in functional disability and return to normal function no disability at 2 hours post-treatment
Together these three objectives provide a comprehensive evaluation of long-term safety efficacy in a large real-world dataset
As part of the sign-up process for the Nerivio app all patients accept the terms of use which specifies that providing personal information is done on their own free will and that their de-identified data may be used for research purposes Users are not obligated to provide personal information and could treat without providing any feedback The app includes a secured personal migraine diary which enables patients to record and track their migraines and other headaches At the beginning of each treatment and again 2 hours after the start of treatment patients are prompted to record their symptoms including pain level none mild moderate severe functional disability None Mild limitation Moderate limitation Severe limitation and an indication of which medications if any were taken within that 2-hour time window
Post-marketing surveillance is designed to assess the safety utilization and efficacy in larger and more diverse populations and in various real-world environments and situations As a digital therapeutic device ie electroceutical the REN device enables prospective collection of electronic patient-reported outcomes in real-world clinical practice
This post-marketing RWE study investigates the safety and efficacy of the Nerivio treatment by analyzing data of patients who used the Nerivio device for consecutive 12 months 1 year the following outcome will be assessed
1 - Safety - all adverse events that were reported within the studys period
2 - Utilization - the number of Nerivio treatments per month
3 - Efficacy - pain relief freedom from pain improvement in functional disability and return to normal function no disability at 2 hours post-treatment
Together these three objectives provide a comprehensive evaluation of long-term safety efficacy in a large real-world dataset
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None