Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-30 @ 9:52 AM
Study NCT ID:
NCT07317427
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-01-05
First Post:
2025-09-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Precise Image for Interventional CT
Sponsor:
Philips Clinical & Medical Affairs Global
Organization:
Study Overview
Official Title:
Clinical Study for Precise Image for Interventional CT for Incisive CT and CT 5300 Systems
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-09
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:
The purpose of this clinical study is to assess the performance of the Precise Image reconstruction algorithm on interventional CT images acquired from adult patients (\>18 years old). The analysis will focus on the performance of Precise Image for scans in which procedural instruments (e.g., needle, probe, screw) are present. Clinical data generated from this study is intended to support a proposed expansion of the Indications for Use of Precise Image.
The study has two objectives:
1. To evaluate the image quality for procedural guidance and procedural confidence of Precise Image compared to the standard-of-care reference (iDose4) for:
* Interventional CT images of adult patients (\>18 years old).
2. To demonstrate non-inferiority of Precise Image to iDose4 for the relevant interventional CT images.
The study has two objectives:
1. To evaluate the image quality for procedural guidance and procedural confidence of Precise Image compared to the standard-of-care reference (iDose4) for:
* Interventional CT images of adult patients (\>18 years old).
2. To demonstrate non-inferiority of Precise Image to iDose4 for the relevant interventional CT images.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: