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| Name | Class |
|---|---|
| Echosens | INDUSTRY |
| Institut National de la Santé Et de la Recherche Médicale, France | OTHER_GOV |
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Explorative study on a medical device with two steps. The first pilot step will be on 8 patients (4 with lymphedema and 4 with venous insufficiency). The main objective is to assess the feasibility of measures by high resolution transient elastography on these pathologic skins, and to define 3 areas for measures.
The second step will be on 136 participants (48 healthy volunteers, 48 with venous insufficiency and 40 with unilateral lymphedema of a limb). The main objective is to quantify, by high resolution transient elastography, the dermal and hypodermal cutaneous fibrosis in limbs with lymphedema and venous insufficiency, and to compare it to healthy skin.
This diagnostic study will be performed in two steps, in the goal of evaluating a new device, called elastograph.
The first pilot step will be on 8 patients (4 with lymphedema and 4 with venous insufficiency). The main objective is to assess the feasibility of measures by high resolution transient elastography on these pathologic skins, and to define 3 areas for measures.
The second step will be on 136 participants (48 healthy volunteers, 48 with venous insufficiency and 40 with unilateral lymphedema of a limb). The main objective is to quantify, by high resolution transient elastography, the dermal and hypodermal cutaneous fibrosis in limbs with lymphedema and venous insufficiency, and to compare it to healthy skin.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 3 groups of subjects | Experimental | 3 groups:
Each group have the same interventions: physical examination, measures by cutometer, high resolution ultrasonography, elastography 30 persons will have a skin biopsy (15 healthy volunteers and 15 patients with venous insufficiency) For patients with lymphedema, all measures will be performed on lymphedema limb and on controlateral healthy limb |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cutometer | Device | 3 measures by cutometer on each area: the mean value will be the final value |
|
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of dermal/hypodermal fibrosis in lymphedema and venous insuffisency |
| One day |
| Measure | Description | Time Frame |
|---|---|---|
| Cutaneous fibrosis measured by cutometer | Cutaneous fibrosis measured by cutometer | One day |
| Cutaneous fibrosis assessed by histology | Cutaneous fibrosis assessed by histology (skin biopsies), using a semi-quantitative scale (0 to 3, from no fibrosis to major fibrosis) Analysis of the samples will be performed altogether at the end of inclusions. |
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Inclusion Criteria:
Patients group
Healthy group
Exclusion Criteria:
Patients group
Healthy group
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| Name | Affiliation | Role |
|---|---|---|
| Annabel MARUANI, MD, PhD | CHRU TOURS | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital of Tours | Tours | 37044 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32187631 | Result | Mofid Y, Faleweei G, Chartier C, Machet L, Vierron E, Gissot V, Tauveront V, Georgescou G, Dujardin PA, Machet MC, Kervarrec T, Patat F, Ossant F, Maruani A. High-Frequency Transient Elastography Prototype to Assess Skin (Dermis) Fibrosis: A Diagnostic Study in Patients with Venous Insufficiency and Controls. Ultraschall Med. 2021 Oct;42(5):503-513. doi: 10.1055/a-1047-3146. Epub 2020 Mar 18. |
| Label | URL |
|---|---|
| Clinical Investigation Center - Technological Innovations | View source |
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| ID | Term |
|---|---|
| D014689 | Venous Insufficiency |
| D008209 | Lymphedema |
| D005355 | Fibrosis |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| D014463 | Ultrasonography |
| D054459 | Elasticity Imaging Techniques |
| ID | Term |
|---|---|
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| High resolution ultrasonography (echography) | Device | Cutaneous echography on the 3 areas, in order to measure skin thickness and echogenicity Measures are blinded to cutometer (by a different investigator) |
|
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| Elastography | Device | 10 measures on the 3 areas (central measures will be doubled) Measures will be performed blinded to cutometer |
|
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| Skin biopsy | Procedure | Skin biopsy of 3 mm in diameter, for 30 participants, to evaluate histological fibrosis |
|
| 12 months |
| Cutaneous thickness measured by high resolution ultrasonography | Cutaneous thickness measured by high resolution ultrasonography (in mm) | One day |
| Clinical score of fibrosis | Clinical score of fibrosis, assessed by a scale from 0 (normal skin) to 3 (severe fibrosis): this score is derived from modified Rodnan skin score used in scleroderma | One day |
| Echogenicity of the dermis and superficial hypodermis | Echogenicity of the dermis and superficial hypodermis assessed by high resolution ultrasonography | One day |
| Assessement of adverse events | Assessement of adverse events (pain with a visual analogic scale from 0 to 100, infections of the site of skin biopsies, others) | 15 days |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |