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

NCT04280679 | Completed

• 1 other identifier: HIFU-VN-002
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

HIFU; High Intensity Focused Ultrasound

Outcome Measures

Primary Outcomes (1)

• Reduction of venous reflux

  As measured by ultrasound

  3 months

Secondary Outcomes (3)

• Emergent Adverse Events

  3 months

• Measurement of the need to use tumescence anesthesia during the procedure

  3 months

• Measurement of the need to use adjunctive procedure for treating the reflux

  3 months

Study Arms (1)

Arm of patient treated by HIFU

OTHER

Compression bandages

Device: Sonovein 2

Interventions

Sonovein 2 DEVICE

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

Arm of patient treated by HIFU

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 involving reflux in the segment to be treated
• 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
• Targeted structure sonographically visible

You may not qualify if:

• Patient is pregnant or nursing
• Known allergic reaction to anesthetic 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 Veins; Varicose Ulcer

Condition Hierarchy (Ancestors)

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

Study Officials

• Alfred OBERMAYER, MD

  Karl Landsteiner Insitut fur 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: February 11, 2020
• First Posted: February 21, 2020
• Study Start: March 3, 2020
• Primary Completion: September 9, 2020
• Study Completion: September 10, 2020
• Last Updated: October 6, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)