Ignite Creation Date:
2024-05-06 @ 8:23 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06366074
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-15
First Post:
2024-04-01
Brief Title:
Early-feasibility Study to Evaluate Usability and Safety of the Watch-Transcutaneous Electrical Acustimulation TEA Device
Sponsor:
University of Michigan
Organization:
University of Michigan
Study Overview
Official Title:
Early-feasibility Study to Evaluate Usability and Safety of the Watch-Transcutaneous Electrical Acustimulation TEA Device
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
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 project is being completed to test the usability and safety of the Watch-Transcutaneous Electrical Acustimulation TEA Device
This is a pilot study that will lead to future projects for cancer patients that may experience chemotherapy-induced symptoms
This is a pilot study that will lead to future projects for cancer patients that may experience chemotherapy-induced symptoms
Detailed Description:
This project will include three different aims aim three is a clinical trial and will be funded by the National Institute of Health NIH In aims 1 and 2 the device hardware and device application will be developed and will not be included in this registration as these are not clinical trials However aim three is being registered early in the project in order to obtain the Notice of Award NOA funding from the NIH Once the NOA has been obtained the registration will be updated
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None