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

NCT03304834 | Completed

• 1 other identifier: HIFU-VV-001
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

HIFU; High intensity focused ultrasound

Outcome Measures

Primary Outcomes (1)

• Reduction of venous reflux

  as measured by ultrasound

  3 months

Secondary Outcomes (2)

• Measurement of flow abolition

  3 months

• Emergent Adverse Events

  3 months

Study Arms (1)

ECHOPULSE

EXPERIMENTAL

Arm of patient treated by HIFU

Device: ECHOPULSE

Interventions

ECHOPULSE DEVICE

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

Also known as: Compression bandage

ECHOPULSE

Eligibility Criteria

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

You may qualify if:

• Candidate for venous procedure involving lower limb superficial insufficiency, recurrence at the thigh/groin level or perforators incompetence.
• Physical condition allowing ambulation after the procedure.
• Availability of the patient for all the follow-up visits.
• Targeted tissue reachable for treatment with the device- meaning between 5mm and 26mm below the skin surface.
• Age over 18 years of age at the time of enrollment.
• No acute venous thrombosis.
• No complete, or near complete deep vein thrombosis.
• Patient has signed a written informed consent.

You may not qualify if:

• Patient is pregnant or nursing
• Known allergic reaction to anesthetics to be used
• Legally incapacitated or imprisoned patients
• Patient participating in another clinical trial involving an investigational drug, device or biologic.

Sponsors & Collaborators

• Theraclion: lead

Study Sites (1)

Karl Landsteiner Institut für funktionelle Phlebochirurgie

Melk, 3390, Austria

Location

MeSH Terms

Conditions

Varicose Ulcer; Varicose Veins

Interventions

Compression Bandages

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Bandages; Equipment and Supplies

Study Officials

• Alfred OBERMAYER, MD

  Karl Landsteiner Institut für funktionelle Phlebochirurgie

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: Monocentric study

Study Record Dates

• First Submitted: October 3, 2017
• First Posted: October 9, 2017
• Study Start: August 21, 2017
• Primary Completion: August 30, 2018
• Study Completion: August 30, 2018
• Last Updated: November 29, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)