Ignite Creation Date:
2024-06-16 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06432335
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-03
First Post:
2024-05-22
Brief Title:
E-Socket Diagnostic Monitoring
Sponsor:
University of Washington
Organization:
University of Washington
Study Overview
Official Title:
E-Socket Diagnostic Monitoring
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
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:
The long-term goal of this research is a socket-embedded prosthesis use and socket fit monitor E-Socket that facilitates clinical decision-making in the diagnosis and prognosis of health issues faced by people with transtibial amputation The overall strategy is to enhance the E-socket to include additional metrics that we identified needed from studies to date Aim 1 Then we conduct a randomized control trial testing the diagnostic utility of the E-socket data in clinical care Aim 2 From the data collected in that study we develop the prognostic capability of the system Aim 3
Aim 3 will not involve human subject testing as it will focus on the development of the system in preparation for a future aim involving participants own clinicians
Note we use the term diagnostic throughout our application in a general sense The device will not be diagnosing specific diseases or medical conditions
Aim 3 will not involve human subject testing as it will focus on the development of the system in preparation for a future aim involving participants own clinicians
Note we use the term diagnostic throughout our application in a general sense The device will not be diagnosing specific diseases or medical conditions
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
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?:
False
Is an FDA AA801 Violation?:
None