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| Name | Class |
|---|---|
| Novotech CRO | UNKNOWN |
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This is an exploratory, international, prospective, interventional, multicenter clinical investigation that will take place in 1 Hong Kong site and 3 French sites and 309 adults patients will be included. The study objective is to assess the LSM reproducibility between the FibroScan examination performed with the Single Probe (SP) and the FibroScan examination performed with the reference probes (M and XL).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All patients | Experimental | Adult patients followed in the Hepatology department for a chronic liver disease, all etiologies combined. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Research FibroScan | Device | *Patients #1 to #50: Exam 1: Examination with Research FibroScan and single probe #1 (SP1). Exam 2: Examination with Research FibroScan and single probe #2 (SP2). Exam 3: Examination with Research FibroScan and single probe #3 (SP3). Exam 4: Examination with the Reference FibroScan at the same measurement point. The examination must start alternatively with the FS exam using the SP1 probe, the SP2 probe or the SP3 probe to avoid potential bias. The standard examination must be always done at the end, after the first 3 exploratory exams. *Patients #51 to #309: Exam 1: Examination with the Research FibroScan. Exam 2: Examination with the Reference FibroScan at the same measurement point. The examination must start alternatively with the Research FibroScan and the Reference FibroScan to avoid potential bias. |
| Measure | Description | Time Frame |
|---|---|---|
| Difference between LSM by guided-VCTE performed with the single probe and LSM by guided-VCTE performed with the reference probes (M and XL). | This outcome assesses the difference between the values of LSM obtained with the single probe and the reference probes (M and XL) when performed in the same patients. | At Day 0 |
| Measure | Description | Time Frame |
|---|---|---|
| Difference between CAP performed with single probe and CAP performed with the reference probes (M and XL). | This outcome assesses the difference between the CAP measurements obtained with the single probe and the reference probes (M and XL) when performed in the same patients. | At Day 0 |
| Difference of patient percentage having a successful examination between the FibroScan (guided-VCTE) examination performed with the single probe and the FibroScan (guided-VCTE) examination performed with the reference FibroScan probes (M and XL probes). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Anne Llorca | Contact | +33144827850 | anne.llorca@echosens.com | |
| Laura Cantu Sanchez | Contact | +33144827850 | laura.cantusanchez@echosens.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHRU de Besançon | Not yet recruiting | Besançon | 25000 | France |
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| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| ID | Term |
|---|---|
| D004066 | Digestive System Diseases |
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This outcome compare the applicability of FibroScan examinations performed with the single probe compared with the reference probes (M and XL). |
| At Day 0 |
| Difference between the values reported by the patient on the comfort scale after a FibroScan (guided-VCTE) examination performed with the single probe and after a FibroScan examination (guided-VCTE) performed with the reference probes (M and XL). | This outcome evaluates the difference in patient-reported comfort following FibroScan examinations performed with the single probe versus the reference probes (M and XL), as reported by patients after undergoing the examinations under similar conditions. A comfort scale from 0 to 10 will be given to the patients, where 10 represents the most confortable and 0 the more incomfortable. | At Day 0 |
| Hôpital St Eloi- CHU Montpellier | Not yet recruiting | Montpellier | 34090 | France |
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| Hôpital Paris Saclay | Not yet recruiting | Orsay | 91400 | France |
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| Prince of Wales Hospital the Chinese University of Hong Kong | Recruiting | Hong Kong | Hong Kong |
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