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An Open-label, Single-dose Pilot Study to Evaluate Varisolve® (Polidocanol Endovenous Microfoam (PEM)) 0.125% [0.2%] for Varicose Veins

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
BTG Ltd.
ClinicalTrials.gov Identifier:
NCT00928421
First received: June 24, 2009
Last updated: September 21, 2011
Last verified: September 2011
History of Changes
  Purpose

To determine the effect and safety of Varisolve® 0.125% [0.2%]


Condition Intervention Phase
Varicose Veins
 Drug: Polidocanol Endovenous Microfoam 0.125%
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-label, Single-dose Pilot Study to Evaluate the Efficacy and Safety of Varisolve® (Polidocanol Endovenous Microfoam) 0.125% [0.2%] for the Treatment of Symptomatic, Visible Varicose Veins With Saphenofemoral Junction (SFJ) Incompetence

Resource links provided by NLM:

MedlinePlus related topics: Varicose Veins
Drug Information available for: Polidocanol
U.S. FDA Resources

Further study details as provided by BTG Ltd.:

Primary Outcome Measures:
  • Physician determined evaluation of PEM and EMA characteristics [ Time Frame: Immediately ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Elimination of reflux through the SFJ. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Complete occlusion of the GSV [ Time Frame: 8 Weeks ] [ Designated as safety issue: No ]

Enrollment: 16
Study Start Date: June 2009
Study Completion Date: January 2010
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Varisolve 0.125% Drug: Polidocanol Endovenous Microfoam 0.125%
Polidocanol Endovenous Microfoam 0.125%, single dose
Other Name: Varisolve 0.125%

Detailed Description:

In patients with SFJ incompetence due to reflux of the Great Saphenous Vein (GSV) or major accessory veins, with venous disease manifested by both symptoms and visible varicosities:

  1. To evaluate PEM and Endovenous Microfoam Ablation(EMA) characteristics of Varisolve® 0.125% [0.2%] as assessed by the treating physician
  2. Using duplex ultrasonography, to evaluate the efficacy of Varisolve® 0.125% [0.2%] as assessed by the elimination of SFJ reflux and/or occlusion of the treated vein
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or female; age of consent to 75 years
  2. Baseline VEINES-Sym Questionnaire score less than 75 points
  3. Superficial venous disease manifested by both symptoms and visible varicosities
  4. Varicose vein clinical classification CEAP 2 through 5
  5. Incompetence of SFJ (reflux > 0.5 seconds on duplex ultrasonography) associated with incompetence of the great saphenous vein (GSV) or other major accessory vein
  6. Ability to comprehend and sign an informed consent document and complete study questionnaires in English

Exclusion Criteria:

  1. Incompetence of the small saphenous vein (SSV)
  2. Ultrasonographic or other evidence of current or previous deep vein thrombosis, occlusion or incompetence
  3. Leg obesity impairing the ability to access the vein to be treated and/or to follow the post-procedural compression recommendations.
  4. Peripheral arterial disease in the leg to be treated contraindicating post-procedural compression.
  5. Reduced mobility (inability to maintain a brisk walk unaided for a minimum of 5 minutes per hour per day).
  6. Planned prolonged automobile, bus, or air travel within 4 weeks following treatment, unless the patient can walk for at least 5 consecutive minutes every hour during travel.
  7. History of pulmonary embolism or stroke.
  8. Major surgery, prolonged hospitalization or pregnancy within 3 months of screening.
  9. Current anticoagulation therapy (within 7 days of enrollment).
  10. Participation in a clinical study involving an investigational pharmaceutical product or device within the 3 months prior to screening.
  11. Previous treatment in this study or in a previous Varisolve® study.
  12. Major co-existing disease (e.g. malignancy; pulmonary disease; renal or hepatic insufficiency; serious skin disease/condition that may compromise the ability of the patient to comply with the compression protocol, etc.) or clinically significant laboratory abnormalities.
  13. Known allergic response to polidocanol, or severe and multiple allergic reactions.
  14. Women of childbearing potential not using effective contraception for at least one month prior to study enrollment and/or unwilling to continue birth control until their last study visit.
  15. Pregnant or lactating women.
  16. Current alcohol or drug abuse.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00928421

Locations
United States, Washington
Bellevue, Washington, United States
Sponsors and Collaborators
BTG Ltd.
Investigators
Study Chair: Ellen Evans BTG Ltd.
  More Information

No publications provided

Responsible Party: BTG Ltd.
ClinicalTrials.gov Identifier: NCT00928421     History of Changes
Other Study ID Numbers: VAP.VV014
Study First Received: June 24, 2009
Last Updated: September 21, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by BTG Ltd.:
Varicose Veins

Additional relevant MeSH terms:
Varicose Veins
Vascular Diseases
Cardiovascular Diseases
Polidocanol
 Sclerosing Solutions
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013