VenaSeal Spectrum: Global Post-Market Randomized Controlled Trial
Stopped: Follow-up of the VenaSeal vs. Endothermal Ablation and Venous Leg Ulcer studies was concluded early due to increased evidence of safety and effectiveness of VenaSeal in published literature and to reduce burden to investigators and sites.
United States506 participantsStarted 2020-02-05
Plain-language summary
Global, Post-Market, Prospective, Multi-Center, Randomized Controlled Trial of the VenaSealâ„¢ Closure System vs. Surgical Stripping or Endothermal Ablation (ETA) for the Treatment of Early and Advanced Stage Superficial Venous Disease
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Patient is ≥18 years of age
✓. Patient has venous reflux in superficial truncal vein(s) (e.g., GSV, SSV, accessory saphenous veins) with CEAP 2 (symptomatic) or CEAP 3, 4a, 4b, 5, 6, appropriate for treatment, as confirmed by Duplex Ultrasound (DUS)
✓. Eligibility for treatment:
✓. Treatable refluxing segment of target vein(s) 10 cm in length or longer
✓. Patient has a target vein diameter of ≥3 mm throughout the intended treated segment of the target vein as measured by DUS while patient is standing
✓. Patient is willing and capable of complying with specified follow-up evaluations at the specified times
✓. Patient has an ability to understand the requirements of the study and to provide informed consent
Exclusion criteria
✕. Patient has a known history of allergic sensitivities (including but not limited to cyanoacrylate adhesives), or any other condition, which in the opinion of the investigator may make the patient more susceptible to cyanoacrylate adhesive hypersensitivity
✕. Patient has known deep vein obstruction in the target limb, as identified by the site's standard of care
✕. Patient has abnormal pulse exam or ABI \<0.8
✕. Patient has acute superficial thrombophlebitis
What they're measuring
1
Randomized Study VenaSealâ„¢ 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.
Timeframe: 30 days
2
Randomized Study VenaSealâ„¢ System Versus Surgical Stripping: Primary Endpoint: Peri-procedural Patient Satisfaction as Measured by a Validated, Patient-centered Venous Treatment Satisfaction Questionnaire (VenousTSQe) at 30 Days.
Timeframe: 30 days
3
Randomized Study VenaSealâ„¢ System Versus Endothermal Ablation (ETA): Primary Endpoint: Patient Satisfaction as Measured by a Validated, Patient-centered Venous Treatment Satisfaction Questionnaire (VenousTSQs) at 30 Days.
Timeframe: 30 days
4
Randomized Study VenaSealâ„¢ System Versus Surgical Stripping: Primary Endpoint: Patient Satisfaction as Measured by a Validated, Patient-centered Venous Treatment Satisfaction Questionnaire (VenousTSQs) at 30 Days.
Timeframe: 30 days
5
Randomized Study VenaSealâ„¢ System Versus Endothermal Ablation (ETA): Primary Endpoint: Elimination of Clinically Relevant Superficial Truncal Disease in Each Target Vein at the Time of Index Procedure.
Timeframe: Post Index procedure, on the day of the procedure immediately following treatment
6
Randomized Study VenaSealâ„¢ System Versus Surgical Stripping: Primary Endpoint: Elimination of Clinically Relevant Superficial Truncal Disease in Each Target Vein at the Time of Index Procedure.
. Patient requires any non-target vein treatments in the contralateral or ipsilateral limb, or any other surgical procedure up tp 30 days pre-procedure and through 3 months post-procedure
✕. Patient has any co-morbid conditions, which in the investigator's opinion may interfere with the patient's compliance with study visits and procedures, or may confound interpretation of study data (e.g., congestive heart failure Class III and IV, non-ambulatory patients, severe hepatic dysfunction, life expectancy \< 1 year)
✕. IFU contraindications:
✕. Patient is non-ambulatory
Timeframe: Post Index procedure, on the day of the procedure immediately following treatment
7
Single Arm Venous Leg Ulcer (VLU) Study: Primary Endpoint: Time to Ulcer Healing, Calculated Through Healing Confirmation and Verified by an Independent Core Laboratory Through 12 Months.