Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06522061
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-22
Brief Title:
Evaluating the Effective and Safe Use of Stream Platform
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Evaluating the Effective and Safe Use of Stream Platform by a Lay User in a Simulated Environment
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Home-Stream
Brief Summary:
The study aims to demonstrate the potential for at-home monitoring using Stream Platform through simulated-use testing Lay users defined as subjects or nonprofessional caregivers will be asked to operate Stream Platform Safety efficacy and usability data will be collected to ensure that users are able to comply with prescribed device use
Additionally clinical testing will be conducted to identify correlations between measurements from Stream Platform and standard laboratory radiological and clinical assessments used for leak detection as part of the current standard of care SOC that may be skipped if the subject is discharged early
Additionally clinical testing will be conducted to identify correlations between measurements from Stream Platform and standard laboratory radiological and clinical assessments used for leak detection as part of the current standard of care SOC that may be skipped if the subject is discharged early
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None