Ignite Creation Date:
2025-12-24 @ 12:17 PM
Ignite Modification Date:
2025-12-27 @ 9:53 PM
Study NCT ID:
NCT06121661
Status:
RECRUITING
Last Update Posted:
2025-05-08
First Post:
2023-10-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
APPRAISE 2.0: Live Trial of the APPRAISE Trauma Decision Support System
Sponsor:
Andrew Tomas Reisner
Organization:
Study Overview
Official Title:
APPRAISE 2.0: Live Trial of the APPRAISE Trauma Decision Support System
Status:
RECRUITING
Status Verified Date:
2025-05
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:
This is a pilot evaluation of the APPRAISE trauma decision-support software system ("the System"). The specific objections are as follows:
1. Evaluate the robustness of the System (i.e., whether the software performs in real-time in accordance with a priori technical specifications during real-time clinical use);
2. Evaluate whether the real-time display of the System causes distraction or confusion to clinicians treating the trauma patient such that its risks exceed its benefits;
3. Collect pilot data to allow for a statistical power analysis to design a future clinical trial evaluating efficacy.
1. Evaluate the robustness of the System (i.e., whether the software performs in real-time in accordance with a priori technical specifications during real-time clinical use);
2. Evaluate whether the real-time display of the System causes distraction or confusion to clinicians treating the trauma patient such that its risks exceed its benefits;
3. Collect pilot data to allow for a statistical power analysis to design a future clinical trial evaluating efficacy.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
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?:
None
Is an FDA AA801 Violation?: