Ignite Creation Date:
2024-05-06 @ 8:18 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06335563
Status:
RECRUITING
Last Update Posted:
2024-04-12
First Post:
2024-03-22
Brief Title:
Augmented Reality Navigation Versus Traditional CT Guidance for Preoperative Localization of Pulmonary Nodules
Sponsor:
Shanghai Pulmonary Hospital Shanghai China
Organization:
Shanghai Pulmonary Hospital Shanghai China
Study Overview
Official Title:
Application of Intelligent Augmented Reality Glasses in Assisting the Localization of Small Pulmonary NodulesA Prospective Randomized Controlled Noninferiority Trial
Status:
RECRUITING
Status Verified Date:
2024-04
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 study aims to conduct a large-sample randomized controlled clinical trial using traditional CT-guided thoracic puncture localization as a comparison to explore the accuracy safety and clinical advantages of Intelligent AR glasses in assisting preoperative localizing of small pulmonary nodules
Detailed Description:
This study is an open-label prospective single-center non-inferiority randomized controlled clinical trial Patients in the Pulmonary Hospital Affiliated to Tongji University who are scheduled to undergo percutaneous puncture localization of small pulmonary nodules are used as the research subjects According to the entry and exit criteria Patients were included in the clinical trial and the enrolled patients were randomly divided into the AR glasses-assisted puncture localizing group experimental group and the CT-guided conventional pulmonary nodule puncture localizing group control group aiming to evaluate the puncture of pulmonary nodules guided by Intelligent AR glasses Non-inferiority of localization compared with conventional CT-guided pulmonary nodule puncture localization
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None