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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-A00987-42 | Other Identifier | ANSM |
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| Name | Class |
|---|---|
| DMS Apelem | INDUSTRY |
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The main objective of this study is to validate the measurement characteristics of a new bone densitometer, the Stratos DR:
The secondary objective of this study is to cross calibrate the measures of bone mineral content (BMC) and bone mineral density (BMD) from the Stratos DR against those of the Discovery A on the whole body and its subregions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| The study population: first 30 patients | Experimental | The study population consists of adult patients referred to the Nuclear Medicine and Medical Biophysics Department of the Nîmes University Hospital for the performance of an osteodensitometric examination. Intervention: Whole body exam using the "Discovery A" Intervention: First whole body exam using the "Stratos DR" Intervention: Second whole body exam using the "Stratos DR" |
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| The study population: last 20 patients | Experimental | The study population consists of adult patients referred to the Nuclear Medicine and Medical Biophysics Department of the Nîmes University Hospital for the performance of an osteodensitometric examination. Intervention: Whole body exam using the "Discovery A" Intervention: First whole body exam using the "Stratos DR" |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Whole body exam using the "Discovery A" | Device | Whole body exam using the "Discovery A" machine made by Hologic. |
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| Measure | Description | Time Frame |
|---|---|---|
| Lin concordance coefficient for fat mass | The cross calibration between the two devices (Stratos vs Discovery) in terms of fat mass and lean mass is estimated by the appreciation of the Lin concordance coefficient. | Day 0 |
| Lin concordance coefficient for lean mass | The cross calibration between the two devices (Stratos vs Discovery) in terms of fat mass and lean mass is estimated by the appreciation of the Lin concordance coefficient. | Day 0 |
| RMS-%CV (root-mean-square coefficient of variation) for total fat mass | Reproducibility will be evaluated in terms of RMS-% CV for calculating the value of the least significant change (LSC). The values of RMS-%CV (root-mean-square coefficient of variation) of the total fat mass and total lean mass will be compared with the limit values recommended by the ISCD. (International Society for Clinical Densitometry) | Day 0 |
| RMS-%CV (root-mean-square coefficient of variation) for total lean mass | Reproducibility will be evaluated in terms of RMS-% CV for calculating the value of the least significant change (LSC). The values of RMS-%CV (root-mean-square coefficient of variation) of the total fat mass and total lean mass will be compared with the limit values recommended by the ISCD. (International Society for Clinical Densitometry) | Day 0 |
| Measure | Description | Time Frame |
|---|---|---|
| Lin's concordance coefficient for Bone Mineral Content | The cross calibration between the two devices (Stratos vs Discovery) in terms of Bone Mineral Content and Bone Mineral Density will be estimated by the study of Lin's concordance coefficient. | Day 0 |
| Lin's concordance coefficient for Bone Mineral Density |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Vincent Boudousq, MD | Centre Hospitalier Universitaire de NÄ«mes | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHRU de Nîmes - Hôpital Universitaire Carémeau | Nîmes | 30029 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25450754 | Result | Neron M, Fatton B, Monforte M, Mares P, de Tayrac R, Letouzey V. [Evaluation of urine postvoid residuals in post-partum period: a prospective and descriptive clinical study]. Prog Urol. 2015 Mar;25(4):211-6. doi: 10.1016/j.purol.2014.09.043. Epub 2014 Oct 22. French. |
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| First whole body exam using the "Stratos DR" | Device | First whole body exam using the "Stratos DR" machine made by the DMS group. |
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| Second whole body exam using the "Stratos DR" | Device | Second whole body exam using the "Stratos DR" machine made by the DMS group. This second exam is required for reproducibility purposes. |
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The cross calibration between the two devices (Stratos vs Discovery) in terms of Bone Mineral Content and Bone Mineral Density will be estimated by the study of Lin's concordance coefficient. |
| Day 0 |