NCT05835284

Clinical Data Collection On Advanced CT System

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 120 (estimated)
• Sponsor: GE Healthcare · Industry
• Sex: All
• Age: 25 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to evaluate the investigational Edge-on Silicon Photon Counting CT device in a clinical setting.

Detailed description

Images from prior standard of care diagnostic CT exams for these subjects will also be collected. Data collected in this study will be used for technology development, scientific evaluation, marketing and education, and regulatory submissions for future products. This is a pre-market, prospective, open-label, non-randomized, single arm data collection clinical study conducted at one site in Sweden.

Conditions

• CT Photon Counting

Interventions

Type	Name	Description
DEVICE	Investigational Edge-on Silicon Photon Counting CT device	Administration of IV contrast material, if applicable, shall be done according to the hospital's SOC. Administration of oral contrast material, if applicable, shall also be done according to the hospital's SOC. Images will then be compared with the previously acquired CT conducted as standard of care. The investigational scan will take approximately 60-120 minutes.

Timeline

• Start date: 2024-06-04
• Primary completion: 2026-03-01
• Completion: 2026-03-01
• First posted: 2023-04-28
• Last updated: 2025-12-04

Locations

1 site across 1 country: Sweden

Regulatory

• FDA-regulated device study