APPRAISE 2.0: Live Trial of the APPRAISE Trauma Decision Support System
NCT06121661 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20
Last updated 2025-05-08
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.
Conditions
- Wounds and Injuries
Interventions
- DEVICE
-
APPRAISE Trauma Clinical Decision Support System
Real-time bedside decision-support system for trauma patient management
Sponsors & Collaborators
-
Andrew Tomas Reisner
lead OTHER
Principal Investigators
-
Andrew Reisner, MD · Massachusetts General Hospital
Study Design
- Allocation
- NA
- Purpose
- DEVICE_FEASIBILITY
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-02-21
- Primary Completion
- 2027-12-14
- Completion
- 2028-12-14
- FDA Device
- Yes
Countries
- United States
Study Locations
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