Clinical Evaluation Of An X-Ray Bone Densitometer:Use Of DXA Technology For Precise Assessment Of Human Body Composition

Last updated: March 13, 2019
Sponsor: Diagnostic Medical Systems
Overall Status: Active - Recruiting

Phase

N/A

Condition

Bone Density

Treatment

N/A

Clinical Study ID

NCT02965742
2015-A00596-43
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

The main objectives of this study are:

  • to assess the concordance of body composition measures between two bone densitometry devices: the STRATOS by Diagnostic Medical Systems (DMS) and the Hologic QDR 4500 A by Hologic inc.

  • to assess the concordance of body composition measures between two bone densitometry devices: the STRATOS by Diagnostic Medical Systems (DMS) and the Hologic HORIZON A by Hologic inc.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • The patient must have given his/her informed and signed consent

  • The patient must be insured or beneficiary of a health insurance plan

  • The patient is referred by a doctor for the performance of an osteodensitometryexamination or sportsmen coming through a protocol where the nuclear medicinedepartment is the investigator center

Exclusion

Exclusion Criteria:

  • The patient is pregnant or nursing

  • The patient is unable to sign or refuse to sign the informed consent

  • The patient has a coronary stent or metal sutures in the heart

  • The patient has any type of metal objects in the body such as an artificial joint, apin or a metal plate

  • The patient has a pacemaker or defibrillator

  • Patient weighing more than 200 kg or more than 2 meters high by 65 centimeters wide

  • The patient is using an insulin pump or with insulin-necked

  • The patient has undergone X-ray examination using a contrast medium such as barium inthe previous seven days visit,

  • Patient who underwent an examination using x rays in the 15 days preceding the visit

  • Patient suffering from generalized edema

Study Design

Total Participants: 50
Study Start date:
February 01, 2016
Estimated Completion Date:
January 31, 2020

Study Description

The secondary objectives of this study are:

  • the assessment of the consistency of body composition measurements at local level (arms, trunk, legs) between the Stratos and Hologic 4500 A,

  • the assessment of the consistency of body composition measurements at local level (arms, trunk, legs) between the Stratos and Hologic HORIZON A,

  • Monitoring the evolution of body composition in patients receiving at least two evaluations of DXA Hologic QDR 4500A on: patients treated for obesity or anorexia nervosa, sports people and other patient with prescription DXA and the assessment the consistency of body composition measurements in terms,

  • Monitoring the evolution of body composition in patients receiving at least two evaluations of DXA Hologic HORIZON A on: patients treated for obesity or anorexia nervosa, sports people and other patient with prescription DXA and the assessment the consistency of body composition measurements in terms.

Connect with a study center

  • Centre Hospitalier Universitaire de Montpellier

    Montpellier, Hérault 34295
    France

    Active - Recruiting

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