UltrasoundNCT06053892
AR US Versus sUS or Fluoroscopic Injections for Shoulder Punction
A study testing Puncture in people with Ultrasound and Interventions, run by Balgrist University Hospital at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Ultrasound, Interventions
- What is being tested?
- Puncture
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteSwitzerland
- Study dates
- 13 Jun 2023to 31 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- - 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)
Who cannot join
- - 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.)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Time for Prucedure, and Effectiveness Between Augmented Reality Enhanced Ultrasound-guided Versus Standard Ultrasound or Fluoroscopic Injections
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
Read the 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.
- Conditions
- Ultrasound, Interventions
- Being tested
- Puncture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PunctureDiagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| AR US | Active comparator | Augmented reality sonography guidance for shoulder punctures Receives: Diagnostic Test: Puncture |
| standard US | Active comparator | standard sonography guidance for shoulder punctures Receives: Diagnostic Test: Puncture |
| Fluoroscopic | Active comparator | Fluroscopic guidance for shoulder punctures Receives: Diagnostic Test: Puncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 10 minutes
Secondary outcomes (1)
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
Measured: 10 minutes (ml aspirated) to 3 days (laboratory results)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2023
- Study start13 Jun 2023
- Primary completion31 Jan 2025
- Study completion31 Jan 2025
Why it stopped: Difficulties in recruiting and implementing the study design due to missing ressources.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for UltrasoundStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Balgrist University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06053892
- Sponsor's protocol ID
- R471
- Status last verified
- Sep 2025
- First submitted
- 15 May 2023
- Last updated
- 8 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Time for Prucedure, and Effectiveness Between Augmented Reality Enhanced Ultrasound-guided Versus Standard Ultrasound or Fluoroscopic Injections
- ClinicalTrials.gov ID
- NCT06053892
- Acronym / sponsor ID
- R471
- Conditions
- Ultrasound, Interventions
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulties in recruiting and implementing the study design due to missing ressources.
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Balgrist University HospitalUniversity, hospital or other
- Study start
- 13 Jun 2023 (actual)
- Primary completion
- 31 Jan 2025 (actual)
- Study completion
- 31 Jan 2025 (actual)
- First posted
- 26 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| AR US | Active comparator | Diagnostic Test: PunctureAugmented reality sonography guidance for shoulder punctures |
| standard US | Active comparator | Diagnostic Test: Puncturestandard sonography guidance for shoulder punctures |
| Fluoroscopic | Active comparator | Diagnostic Test: PunctureFluroscopic guidance for shoulder punctures |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- - 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)
Key exclusion criteria (3 listed)
- - 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.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PunctureShoulder 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. | Diagnostic test | AR US, Fluoroscopic, standard US |
Primary outcome
Augmented reality sonography is less time consuming
Time frame: 10 minutes
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
1 secondary outcome
Sonography is more efficient than fluoroscopic- guidance in shoulder puncturing
Time frame: 10 minutes (ml aspirated) to 3 days (laboratory results)
Results and safety
The study was stopped early (reason given: Difficulties in recruiting and implementing the study design due to missing ressources.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2025.
- Individual participant dataSharing planned: No
Related trials for Ultrasound
Not yet recruiting
FUS Neuromodulation for Binge Eating Disorder
Binge-Eating Disorder
Not yet recruiting
Ultrasound-Guided Radiofrequency Ablation for Focal Adenomyosis
Adenomyosis, Adenomyoma of Uterus
Recruiting
Modulating Escape Using Focused Ultrasound
Anxiety Disorders
Not yet recruiting
Bioimpedance and Multiparametric Ultrasound-Guided Fluid Management After Kidney Transplantation
Kidney Transplantation, Delayed Graft Function
Recruiting
Effect of Ultrasonic and Diode Laser Activated Irrigation on Postoperative Pain Following Root Canal Treatment
Symptomatic Irreversible Pulpitis and Symptomatic Apical Periodontitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Puncture in people with Ultrasound and Interventions, run by Balgrist University Hospital at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 8 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Difficulties in recruiting and implementing the study design due to missing ressources.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Augmented reality sonography is less time consuming (time frame: 10 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2025.