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

NCT04280679 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2020-10-06

No results posted yet for this study

Summary

This is a one-arm, open label, prospective, single center study to evaluate clinical standardization with Theraclion's Sonovein 2 HIFU device.

The original Sonovein device was tested in a clinical trial in 50 subjects and received CE Mark. That device has been updated yielding the current version of Sonovein 2. Based on the technical similarities between both devices in term of design, performance and principle of operation, the clinical data for Sonovein is sufficient to assure conformity of the Sonovein 2 with the respected essential requirements. At the same time, the compagny wishes to pursue the standardisation of the clinical practice with the second generation device and is, therefore, conducting this limited trial in 20 evaluable cases (from the planned 22 patients to be included). A "case" is defined as procedure conducted on a distinct vein.

Conditions

  • Varicose Veins
  • Veins Diseases
  • Varicose Ulcer

Interventions

DEVICE

Sonovein 2

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

Sponsors & Collaborators

  • Theraclion

    lead INDUSTRY

Principal Investigators

  • Alfred OBERMAYER, MD · Karl Landsteiner Insitut fur 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
2020-03-03
Primary Completion
2020-09-09
Completion
2020-09-10

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 NCT04280679 on ClinicalTrials.gov