VenaSeal Spectrum: Global Post-Market Randomized Controlled Trial

Conditions

• Venous Reflux

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• VenaSeal™ System — DEVICE
  The VenaSeal™ System is the non-tumescent, non-thermal, non-sclerosant device that uses a proprietary medical adhesive delivered endovenously to close the vein.
• Endothermal Ablation (ETA) — DEVICE
  ETA includes EVLA that uses laser or RFA that uses radiofrequency heating to close the vein. Heat is applied in both EVLA and RFA therapies to close the vein. Subject can be treated with either EVLA or RFA if randomized to ETA arm per site's standard practice.
• Surgical Stripping — PROCEDURE
  Surgical stripping involves stripping (removal) of the diseased vein via surgical procedures.

Study Details

Global, Post-Market, Prospective, Multi-Center, Randomized Controlled Trial of the VenaSeal™ Closure System vs. Surgical Stripping or Endothermal Ablation (ETA) for the Treatment of Early and Advanced Stage Superficial Venous Disease

Key Dates

First listed

Jan 29, 2019

Start date

Feb 5, 2020

Status verified

Jul 2026

Primary completion

Jun 12, 2024

Completion

Nov 10, 2025

Study Design

Enrollment

506 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Randomized study VenaSeal™ System versus Endothermal Ablation (ETA): VenaSeal™ System
  CEAP 2-5 subjects will be randomized to VenaSeal™ System vs. ETA
• Active Comparator: Randomized study VenaSeal™ System versus Endothermal Ablation (ETA): ETA
  CEAP 2-5 subjects will be randomized to VenaSeal™ System vs. ETA
• Experimental: Randomized study VenaSeal™ System versus Surgical Stripping: VenaSeal™ System
  CEAP 2-5 subjects will be randomized to VenaSeal™ System vs. Surgical Stripping
• Active Comparator: Randomized study VenaSeal™ System versus Surgical Stripping: Surgical Stripping
  CEAP 2-5 subjects will be randomized to VenaSeal™ System vs. Surgical Stripping
• Experimental: Single arm Venous Leg Ulcer (VLU) Study: VenaSeal™ System
  CEAP 6 active leg ulcer subjects will not be randomized to a comparator, all subjects will be treated with VenaSeal™ System

Primary Outcome Measure

Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Primary Endpoint: Peri-procedural Patient Satisfaction as Measured by a Validated, Patient-centered Venous Treatment Satisfaction Questionnaire (VenousTSQe) at 30 Days. [ Time Frame: 30 days ]

Locations (12)

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