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Rheumatoid Arthritis Handscanner Observational Study. ‘Ontstekingsdetectie met behulp van licht’.

RA-HANDSCANNER OBSERVATIONAL STUDY.

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON24015
Enrollment
70
Registered
2012-01-11
Start date
2012-01-09
Completion date
Unknown
Last updated
2024-02-28

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

Conditions

Rheumatoid Arthritis

Interventions

None listed

Sponsors

Sponsor: Akeso Medical Imaging Perfomer: UMC Utrecht, Regionaal Reumacentrum Eindhoven
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Diagnosed with rheumatoid arthritis for groups II-IV; 2. Age range between 18 and 90 years; 3. Ability to give informed consent.

Exclusion criteria

Exclusion criteria: 1. Diagnosed with an inflammatory joint disease for group I; 2. Significant visual deformations of the hand and fingers; 3. Recent surgery or operation in the last three months on wrist, hand or fingers; 4. Wheelchair bound patients; 5. Pregnancy or breastfeeding; 6. Light sensitivity, i.e. Erythropoietic protoporphyria; 7. Allergy to Gadolinium contrast for group II; 8. Metal objects in any organ or joint for group II; 9. Renal insufficiency defined as MDRD < 30ml/min/1.73m2 for group II.

Design outcomes

Primary

MeasureTime frame
The primary objective of this study is to create an algorithm for the Full Handscan Proto.

Secondary

MeasureTime frame
Secondary parameters are related to variables that may interfere with the optical measurements: 1. Effect of gadolinium i.v. on Full Hand Proto scanning after MRI testing; 2. Observed destruction and erosions in the joints of the hands and wrists, based on the most recent, or upcoming x-ray image as obtained during regular treatment; 3. Temperature; 4. Skin type (Caucasian, Mediterranean , Asian or Negroid); 5. Wounds; 6. Vasodilatative medication; 7. Vasoconstrictive diseases like Raynaud’s disease.

Contacts

Public ContactWouter Rensen

Akeso Medical Imaging Torenallee 20, unit 7.034

wouter@akeso-medical.com+31 (0)40 3020054

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)