NCT06121661

APPRAISE 2.0: Live Trial of the APPRAISE Trauma Decision Support System

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Andrew Tomas Reisner · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
DEVICE	APPRAISE Trauma Clinical Decision Support System	Real-time bedside decision-support system for trauma patient management

Timeline

• Start date: 2023-02-21
• Primary completion: 2027-12-14
• Completion: 2028-12-14
• First posted: 2023-11-08
• Last updated: 2025-05-08

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study