Minimally Invasive Treatment of Primary Great Saphenous V... | NCT05193643

Studies
Minimally Invasive Treatment of Primary Great Saphenous Vein (GSV) Insufficiency Using High Intensity Focused Ultrasound (HIFU)

NCT05193643

Sponsor

Englewood Hospital and Medical Center

Status

Completed

Last Update Posted

Apr 19, 2023Actual

Enrollment

20Actual

Phase

Not Applicable

Conditions

Great Saphenous Vein Insufficiency

Interventions

Sonovein Treatment

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 23, 2022Actual

Primary Completion Date

Oct 8, 2022Actual

Completion Date

Jan 31, 2023Actual

First Submitted Date

Jan 3, 2022

First Submission Date that Met QC Criteria

Jan 3, 2022

First Posted Date

Jan 18, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 18, 2023

Last Update Posted Date

Apr 19, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Yes

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Sonovein Treatment	Experimental		Device: Sonovein Treatment

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Sonovein Treatment	Device	The Sonovein System provides High Intensity Focused Ultrasound (HIFU) ablation of soft tissue. The energy is delivered via an extra-corporeal treatment probe, which includes an imaging system. The high-energy ultrasound waves propagate through the skin and are focused on a portion of the target tissue, generating intense heat and causing local cell apoptosis and progressive tissue volume reduction over the following months in the tissue within the focal area. The process is then repeated in a stepwise fashion to destroy the targeted tissues.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Technical Feasibility	Technical feasibility of the procedure in terms of the procedure technical success rate	3 months

Secondary Outcomes

Measure	Description	Time Frame
Ablation of venous reflux	- Ablation of venous reflux (as measured by Duplex ultrasound)	3 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

-

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

22 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Type	Date	Date Unknown
Release	Apr 3, 2026
Reset	Apr 23, 2026