Bone Evaluation by Ultrasound Radiofrequency Echographic Multi Spectrometry (REMS) vs Dual X-ray Absorptiometry (DXA)
Recruiting · NCT06371755 · Interventional (participants receive a specific treatment) · Lead sponsor: Paola Pisani
View the official record on ClinicalTrials.gov →Interventions studied
Ultrasound examination with REMS technology
What this trial is about
Bone Density Evaluation by means of the Ultrasound Technology Named Radiofrequency Echographic Multi Spectrometry (REMS) in Comparison With DXA Technique. Clinical Center involved in the study:IRCCS Orthopedic institute Galeazzi - Sant'Ambrogio The clinical study will evaluate the intra- and inter-operator repeatability of the REMS,(Radiofrequency Echographic Multi Spectrometry) ultrasound diagnostic technology implemented in the EchoStation device (Echolight Spa, Lecce) and the diagnostic accuracy in comparison with DXA (used as standard reference).
Who can take part
Age range
30 Years to 80 Years
Sex
Female
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- patients scheduled for lumbar and/or femoral DXA examination,
- female sex,
- age range 30-80 years (for repeatability study), age range 50-70 years (for accuracy study),
- absence of severe obesity (BMI \< 40 kg/m2),
- absence of severe walking difficulties,
- cognitive underwriting of informed consent.
Exclusion criteria
- Male sex,
- severe walking difficulties,
- age below 30 years or over 80 years,
- severe obesity (BMI \> 40 kg/m2),
- declared pregnancy.
Where it is running
1 location listed.
- I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio - Milan, MI, Italy