Volume Estimation of the Limb After VEnous Treatment
Palavras-chave
Resumo
Descrição
At admission eligible patients are proposed to participate. Written consent is signed after complete oral and written explanation of the protocol is signed. No register of non-included patients will be kept.
In included patients, in parallel to the routine ultrasound investigation for which the patient is referred, the evaluation of the variation of the volumes of the lower limbs with the volumetric 3D scanner will be performed as explained later in arm description.
Usual ongoing treatments are obtained by history and recorded. The end of the visit is the end of the participation of the subjects.
datas
Última verificação: | 10/31/2019 |
Enviado pela primeira vez: | 01/17/2018 |
Inscrição estimada enviada: | 10/10/2018 |
Postado pela primeira vez: | 10/11/2018 |
Última atualização enviada: | 11/04/2019 |
Última atualização postada: | 11/05/2019 |
Data real de início do estudo: | 11/26/2018 |
Data Estimada de Conclusão Primária: | 11/25/2020 |
Data Estimada de Conclusão do Estudo: | 12/25/2021 |
Condição ou doença
Intervenção / tratamento
Device: Lower limb volume estimation
Fase
Grupos de Armas
Braço | Intervenção / tratamento |
---|---|
Experimental: Lower limb volume estimation Patients referred for a preoperative venous assessment as part of an indication for interventional management, whether by conventional or endovascular surgery, of a chronic venous pathology.
Intervention is measurement of lower limb volume with scanner 3D system before and after surgery or vascular intervention. | Device: Lower limb volume estimation The 3D scanner system is a three-dimensional measurement system.
It allows to evaluate the volume of the lower limbs in order to quantify the evolution of the edema of the lower limbs in the venous pathology in pre and post therapeutic technique.
It is a non-invasive, easily accepted, non-invasive, non-invasive technique that minimizes discomfort. |
Critério de eleição
Idades qualificadas para estudar | 18 Years Para 18 Years |
Sexos elegíveis para estudo | All |
Aceita Voluntários Saudáveis | sim |
Critério | Inclusion Criteria: - subjects referred for investigation of a preoperative venous assessment - affiliation to the French National healthcare system - french speaking patients Exclusion Criteria: - pregnancy - inability to understand the study goal - patients protected by decision of law |
Resultado
Medidas de Resultado Primário
1. Volume of lower limbs [12 months]
Medidas de Resultado Secundário
1. Change in symptoms and quality of life [12 months]
2. Change in symptoms and quality of life [12 months]
3. Change in symptoms and quality of life [12 months]
4. Change in symptoms and quality of life [12 months]
5. Validity [1 hour]