Trials / Completed
CompletedNCT04006184
Retrospective Review of Saphenous Vein Incompetence: Venaseal Versus Endovenous Thermal Ablation
Venaseal Versus Ablation With Endothermal Laser or Radiofrequency for Saphenous Vein Incompetence: a Comparison of Utilization of Adjunctive Phlebectomy
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 547 (actual)
- Sponsor
- Lake Washington Vascular · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This study is a retrospective, chart review of treatment of patients with symptomatic varicose veins. Treated limbs must have the Great Saphenous Vein and/or Small Saphenous Vein treated with either cyanoacrylate closure (VenaSeal) or Endothermal Ablation (either Radiofrequency Ablation or Endovenous Laser Ablation).
Detailed description
This single site, retrospective, comparison study aims to review up to 400 treated limbs with symptomatic varicose veins to compare the need for/utilization of adjunctive phlebectomy performed as a concomitant or staged procedure in conjunction with either cyanoacrylate closure versus endothermal ablation of incompetent saphenous veins through 6 months of the index procedure. The overall cost of treatment for both groups will be compared. Some of the secondary aims of this study include: 1. To assess changes in Clinical, Etiology, Anatomy, and Pathology (CEAP) clinical class after completion of treatment. 2. To assess changes in revised Venous Clinical Severity Score (rVCSS) and compare the two groups. 3. To assess the need for adjunctive therapies. 4. To record and compare retrospectively the adverse events between the two groups.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Chart review | Retrospective review of medical records at a single site with six physicians |
Timeline
- Start date
- 2019-06-14
- Primary completion
- 2019-07-30
- Completion
- 2019-08-30
- First posted
- 2019-07-05
- Last updated
- 2019-10-03
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT04006184. Inclusion in this directory is not an endorsement.