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Assessing the concordance between an AI-Based Robotic Ultrasound System and Conventional Expert Ultrasound in Inflammatory and Structural Joint Assessment – the PIX-ROBO Study

Assessing the concordance between an AI-Based Robotic Ultrasound System and Conventional Expert Ultrasound in Inflammatory and Structural Joint Assessment – the PIX-ROBO Study - PIX-ROBO

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00040439
Enrollment
200
Registered
2026-05-22
Start date
2026-04-17
Completion date
Unknown
Last updated
2026-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

M06.9

Interventions

Group 1: Patients will be observed over a 104 week period. Every 26 weeks a robotic ultrasound (RUS) as well as a conventional ultrasound (CUS) will be performed. During these visits, clinical assessm

Sponsors

Medizinische Universität Wien
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: - Diagnosis of rheumatoid arthritis (RA) or psoriatic arthritis (PsA) according to the 2010 American College of Rheumatology (ACR)/ European Alliance of Associations for Rheumatology (EULAR) or Classification Criteria for Psoriatic Arthritis (CASPAR) criteria respectively - Willing and capable of giving informed consent, which must be obtained prior to any study-specific screening procedures - Evidence of active arthritis, as shown by 1 or more clinically swollen joints among those scanned by ultrasound - Willing and able to comply with scheduled visits, laboratory tests, and other study procedures - Willing and able to comply with the RUS system

Exclusion criteria

Exclusion criteria: - Unable to comprehend instructions necessary to perform the RUS examination - Severe joint destruction, defined as previous amputation, joint surgery or deformation that prohibits the placing of hands on the examination table required for performing the RUS examination

Design outcomes

Primary

MeasureTime frame
Agreement and reliability (measured via weighted kappa statistics) between synovitis assessed by RUS and CUS on the joint level, to determine concordance between RUS and CUS.

Secondary

MeasureTime frame
Agreement and reliability (measured via weighted kappa statistics) between osteophytes assessed by RUS and CUS on the joint level, to determine concordance between RUS and CUS.

Countries

Austria, Denmark, Germany, Switzerland

Contacts

Public ContactPeter Mandl

Medizinische Universität Wien

peter.mandl@meduniwien.ac.at+4314040043010

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Jun 11, 2026