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Clinical Trials/NCT05193643
NCT05193643CompletedNot Applicable

Minimally Invasive Treatment of Primary Great Saphenous Vein (GSV) Insufficiency Using High Intensity Focused Ultrasound (HIFU) Generated by Sonovein: A Single Center Prospective Feasibility Study

Englewood Hospital and Medical Center2 sites in 1 country20 target enrollmentStarted: March 23, 2022Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
20
Locations
2
Primary Endpoint
Technical Feasibility
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

This is a one-arm, open label, prospective, single-center study. Primary objective To evaluate the feasibility of HIFU for treatment of Great Saphenous Vein using assessments of patient experience and response to treatment.

Secondary objective To assess the general safety and ablation rate outcomes following HIFU treatment of GSV

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
22 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Candidate for venous procedure with primary GSV insufficiency involving reflux in the segment to be treated
  • •CEAP-clinical classification ≥ 2
  • •Physical condition allowing ambulation after the procedure.
  • •Agree to comply with the Clinical investigation plan and follow-up schedule of the study
  • •Targeted tissue reachable for treatment with the device - meaning between 5mm and 24mm below the skin surface.
  • •Age over 22 years at the time of enrollment.
  • •No acute venous thrombosis.
  • •No complete or near complete deep vein post-thrombotic disease.
  • •Patient has signed and understood the written informed consent.
  • •Exclusion criteria
  • •Patient is pregnant
  • •Known allergic reaction to anesthetics to be used.
  • •Legally incapacitated or imprisoned patients
  • •Patient's vein target not clearly visible on the ultrasound images (in B mode) at the inclusion visit.
  • •Patient participating in another clinical trial involving an investigational drug or device.
  • •Ankle-brachial index <7 (ABI)
  • •Undergoing active anticoagulant therapy within the last 6 months
  • •Diameter of the treated anatomical segment below ≤ 2mm

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Technical Feasibility

Time Frame: 3 months

Technical feasibility of the procedure in terms of the procedure technical success rate

Secondary Outcomes

  • Ablation of venous reflux(3 months)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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