Volume Estimation of the Limb After VEnous Treatment

NCT03703765 | Completed DMC

• 1 other identifier: 2017-A02698-45
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Venous Disease

Keywords

Volume; veins; lower limb; imaging

Outcome Measures

Primary Outcomes (1)

• Volume of lower limbs

  Change of volume of the lower limbs will be assessed with a volumetric 3D scanner

  12 months

Secondary Outcomes (5)

• Change in symptoms and quality of life

  12 months

• Change in symptoms and quality of life

  12 months

• Change in symptoms and quality of life

  12 months

• Change in symptoms and quality of life

  12 months

• Validity

  1 hour

Study Arms (1)

Lower limb volume estimation

EXPERIMENTAL

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

Interventions

lower limb volume estimation 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.

Lower limb volume estimation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• subjects referred for investigation of a preoperative venous assessment
• affiliation to the French National healthcare system
• french speaking patients

You may not qualify if:

• pregnancy
• inability to understand the study goal
• patients protected by decision of law

Sponsors & Collaborators

• University Hospital, Angers: lead

Study Sites (1)

UH Angers

Angers, 49100, France

Location

Study Officials

• HENNI MD SAMIR, PhD

  University Hospital, Angers

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 18, 2018
• First Posted: October 12, 2018
• Study Start: November 27, 2018
• Primary Completion: March 30, 2022
• Study Completion: March 30, 2022
• Last Updated: June 11, 2024

Record last verified: 2024-06

Locations

FR (1)