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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02814591
Other study ID # 09/0423
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date October 2011
Est. completion date June 2025

Study information

Verified date November 2022
Source University College, London
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

In this study spatially offset Raman spectroscopy (SORS), which allows the collection of Raman spectra through turbid media, is being applied to collect Raman spectra of bone. The principal aim to find ways to use Raman spectroscopy to assess bone quality in vivo.


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Study Design


Intervention

Device:
spatially offset Raman spectrometer (SORS)
Raman spectra will be collected non-invasively from patients using a lower power 830 nm laser. A probe is brought into gentle contact with the patients skin and measurements taken. The laser power has a pre-defined safe threshold of 30 mW into a 3.5 mm diameter aperture. Built in device safety features prevent this threshold from being exceeded. The probe that comes into patient contact is suitable for disinfecting.

Locations

Country Name City State
n/a

Sponsors (3)

Lead Sponsor Collaborator
University College, London Royal National Orthopaedic Hospital NHS Trust, Science & Technology Facilities Council

Outcome

Type Measure Description Time frame Safety issue
Primary SORS Raman spectral fingerprint for bone disease types and changes over time Individual patient data will be pre-processed and extracted after patient participation visits. As cohorts are filled multivariate classification models will be built to validate disease discrimination and validation of the SORS technique. SORS Raman spectral features will be evaluated using a variety of multi-variate analytical tools e.g. BTEM at time zero and a repeat measure within a year.
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