Volume Estimation of the Limb After VEnous Treatment

NCT ID: NCT03703765

Last Updated: 2024-06-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-11-27
• Study Completion Date: 2022-03-30

Brief Summary

Chronic venous disease encompasses a broad spectrum of clinical presentations and is considered the most common vascular disease. Its causes are diverse, including primary defects of the wall or valves, chronic venous insufficiency, or lesions secondary to thrombosis, a post-thrombotic venous disease, affecting the superficial or deep venous network or both. The major symptom of venous disease is the enlargement of the lower limbs, which can result in edema. The evaluation of the volume of the lower limbs is very important in the diagnosis and follow-up of the venous pathology. There is a great variability of clinical pictures making it difficult to choose the therapeutic gesture. Endovascular venous interventions and conventional venous surgery are major advances in the treatment of venous disease. The variation of lower limb volume in pre and post procedure is a determining factor; thus orienting clinicians for post interventional therapeutic monitoring. Indeed the management of venous disease is multidisciplinary, it involves the cooperation of several specialists as part of its monitoring and its therapeutic management. Our collaborative group includes the Adult and Child Vascular Investigations Department, the Vascular Clinic, the Cardiovascular and Thoracic Surgery Department, and the Interventional Radiology Department. The evaluation of the variation of the volumes of the lower limbs is a capital data for the various specialists for the care in pre and post procedure. A volumetric 3D scanner system guarantees a reliable measurement ensuring optimal evolution and therapeutic follow-up.

Detailed Description

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.

Conditions

Venous Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

lower limb volume estimation

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Angers

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

HENNI MD SAMIR, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Angers

Locations

UH Angers

Angers, , France

Countries

France

Other Identifiers

2017-A02698-45

Identifier Type: -

Identifier Source: org_study_id