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Treatment of Insufficient Superficial and Perforating Veins of the Lower Limb Using HIFU

NCT03304834 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2018-11-29

No results posted yet for this study

Summary

This is a single-center prospective study with a planned accrual of 35 patients with diagnosed symptomatic Lower Limb Veins System (Superficial, Perforating) Insufficiency (including recurrence at the thigh/groin level after previous treatment). The eligible patients must present a symptomatic Leg Veins System Insufficiency diagnosis which fulfills the inclusion/exclusion criteria. All patients will be consented at a Pre-Study Visit and evaluated for eligibility and for baseline characteristics of the disease. Patients will return to clinic on a separate day for the HIFU treatment. Device performance parameters will be collected during the HIFU visit. At follow-up visits at 3 days, 7 days and 3 months, changes in veins and flow characteristics will be evaluated by ultrasound and physical exam, and patient well-being, including pain and anxiety, will be evaluated by patient-reported VAS evaluations. Continued follow-up for a total of 3 months will be completed prior to subject study exit. Adverse events (AE) will be assessed at every study visit following HIFU treatment. An interim Safety Report will be issued after the first 5 patients will arrive at the 7 days visit and will be provided to the Ethics Committee. A second report will be issued once the first 5 patients will complete the follow-up period of 30 days and will be also provided to the Ethics Committee.

Conditions

  • Varicose Ulcer
  • Veins Diseases
  • Vein, Varicose

Interventions

DEVICE

ECHOPULSE

Patient are treated with the HIFU device and the physician is doing a compressive bandage.

Sponsors & Collaborators

  • Theraclion

    lead INDUSTRY

Principal Investigators

  • Alfred OBERMAYER, MD · Karl Landsteiner Institut für funktionelle Phlebochirurgie

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-08-21
Primary Completion
2018-08-30
Completion
2018-08-30

Countries

  • Austria

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03304834 on ClinicalTrials.gov