Ignite Creation Date:
2025-12-24 @ 3:28 PM
Ignite Modification Date:
2025-12-25 @ 1:44 PM
Study NCT ID:
NCT06053892
Status:
TERMINATED
Last Update Posted:
2025-09-08
First Post:
2023-05-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
AR US Versus sUS or Fluoroscopic Injections for Shoulder Punction
Sponsor:
Balgrist University Hospital
Organization:
Study Overview
Official Title:
Comparison of Time for Prucedure, and Effectiveness Between Augmented Reality Enhanced Ultrasound-guided Versus Standard Ultrasound or Fluoroscopic Injections
Status:
TERMINATED
Status Verified Date:
2025-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Difficulties in recruiting and implementing the study design due to missing ressources.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this clinical trial is to prospectively evaluate the potential benefits of injections with Augmented Reality enhanced Ulrasound versus standard Ultrasound or fluoroscopy participants where assigend for fluoroscopic joint injections oder for Ultrasound guided injection.
The main question\[s\] it aims to answer are:
* The primary objective is to evaluate the duration of the different interventions
* the count of needle passes
* assess the reduction of radiation exposure using AR US rather than fluoroscopic guidance for joint injections
The main question\[s\] it aims to answer are:
* The primary objective is to evaluate the duration of the different interventions
* the count of needle passes
* assess the reduction of radiation exposure using AR US rather than fluoroscopic guidance for joint injections
Detailed Description:
Patients assigned for standard Ultrasound or fluoroscopic joint injection are informed about the trial. Participants are randomly assigned to the study or control intervention. 1:1 randomization is used.
In both groups, data on duration of the intervention, count of needle passes, correctness of injection location and radiation exposure will be collected. The outcome measures will be compared between the groups.
In both groups, data on duration of the intervention, count of needle passes, correctness of injection location and radiation exposure will be collected. The outcome measures will be compared between the groups.
Study Oversight
Has Oversight DMC:
True
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?: