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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06053892
Other study ID # R471
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date September 30, 2023
Est. completion date December 31, 2026

Study information

Verified date September 2023
Source Balgrist University Hospital
Contact Nadja Farshad, MD
Phone +41443863320
Email nadja.farshad@balgrist.ch
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 100
Est. completion date December 31, 2026
Est. primary completion date December 31, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - - Patients 18 to 99 years of age - Patients assigned for fluoroscopic guided injections (including MR arthrographies) - Patients assigned for US guided injections (including MR arthrographies) Exclusion Criteria: - - Patients who are not willing to be part of the study - Contraindication against fluoroscopic guided injection - Women who are pregnant or breast feeding (Pregnancy assessment is part of the routine prior to fluoroscopic joint injections. No pregnancy test will be done for this study.)

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
Puncture
Shoulder puncture with the newly designed technique using AR to overlie the US image to the imaged anatomical structures in comparision to standard US and flurosopic-guidance.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Balgrist University Hospital

Outcome

Type Measure Description Time frame Safety issue
Primary Augmented reality sonography is less time consuming Puncturing shoulders with Augmented reality sonography is faster (measuring the time in minutes and seconds) than when using standard sonography- from point of entry the skin until the target 10 minutes
Secondary Sonography is more efficient than fluoroscopic- guidance in shoulder puncturing More fluid (measured in ml) can be aspirated with lower false negative results (laboratory results) when puncutring shoulders with US-guidance in comparison to fluoroscopic guidance 10 minutes (ml aspirated) to 3 days (laboratory results)
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