European Sapheon™ Closure System Observational ProspectivE (eSCOPE) Study

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Sapheon, Inc.
ClinicalTrials.gov Identifier:
NCT01570101
First received: March 26, 2012
Last updated: March 6, 2014
Last verified: March 2014
  Purpose

The primary objective for this clinical study is to assess the role of the CE Marked Sapheon Closure System in closure of incompetent great saphenous veins "GSV" in a routine clinical setting.


Condition
Venous Insufficiency of Leg

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Post Market Study - "European Observational Study of the Sapheon™ Closure System for the Definitive Treatment of Incompetent Great Saphenous Veins: A Prospective Single Arm Multicenter Clinical Observational Study"

Further study details as provided by Sapheon, Inc.:

Primary Outcome Measures:
  • Comparative Duplex Ultrasound [ Time Frame: Immediately Post-procedure ] [ Designated as safety issue: No ]
    The Primary endpoint is a change in duplex ultrasound immediately post-procedure as compared to the pre-procedure duplex ultrasound, proving great saphenous vein closure with lack of pathological reflux.


Secondary Outcome Measures:
  • Safety [ Time Frame: Immediately post-op through 6 month Follow-up "FU" ] [ Designated as safety issue: Yes ]
    The Secondary endpoint is safety, reflected by the rate of occurrence of all adverse events (procedure and non-procedure related; serious and non-serious).


Estimated Enrollment: 80
Study Start Date: December 2011
Estimated Study Completion Date: July 2015
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Detailed Description:

This is a post market, observational study of closure of the great saphenous vein "GSV". Efficacy and safety (adverse events) will be compared to appropriate literature reports to determine if the results of the treatment of reflux disease with the Sapheon Closure System are consistent with or better than the expectations of the medical community for alternative treatments, specifically Laser Thermal Ablation and Radiofrequency Ablation. Additional comparison points may include measurements of pain and/or length of time to return to work.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Subjects presenting at primary care clinics/doctors clinics who meet the eligibility criteria will be enrolled sequentially.

Criteria

Inclusion Criteria:

  • Age ≥18 years and ≤ 70 years of age.
  • Symptomatic primary Great Saphenous Vein "GSV" incompetence diagnosed by clinical symptoms, with or without visible varicosities, and confirmed by duplex ultrasound imaging.
  • CEAP classification of C2, C3 or C4.
  • Ability to walk unassisted.
  • Ability to attend follow-up visits.
  • Ability to understand the requirements of the study and to provide written informed consent.
  • "GSV" on standing pre-procedure Doppler Ultrasound ≥3mm and ≤10mm (maximum diameter).

Exclusion Criteria:

  • Life expectancy < 1 year.
  • Regular pain medication.
  • Anticoagulation including Heparin or Coumadin.
  • Previous Deep Vein Thrombosis "DVT".
  • Previous superficial thrombophlebitis in "GSV".
  • Previous venous treatment on target limb.
  • Known Hyper-coagulable disorder.
  • Conditions which prevent routine vein treatment like:

    • Acute disease,
    • Immobilization or inability to ambulate, and
    • Pregnancy.
  • Tortuous "GSV", which in the opinion of the Investigator will limit catheter placement. (no 2 primary access sites allowed).
  • Incompetent ipsilateral small saphenous or anterior accessory great saphenous vein.
  • Known sensitivity to the cyanoacrylate "CA" adhesive.
  • Current participation in another clinical study involving an investigational agent or treatment, or within the 30 days prior to enrollment.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01570101

Locations
Denmark
Aareknudeklinikken
Naestved, Denmark, 4700
Germany
Dermatologikum
Hamburg, Germany, 20354
Klinik Proebstle
Mannheim, Germany, D - 68161
United Kingdom
Countess of Chester Hospital NHS Foundation Trust
Chester, United Kingdom, CH2 1UL
The Whiteley Clinic
Guildford, United Kingdom, GU2 7RF
Charing Cross Hospital
London, United Kingdom, W6 8RF
Sponsors and Collaborators
Sapheon, Inc.
Investigators
Principal Investigator: Thomas Proebstle, MD Klinik Proebstlé
  More Information

No publications provided

Responsible Party: Sapheon, Inc.
ClinicalTrials.gov Identifier: NCT01570101     History of Changes
Other Study ID Numbers: CP-10763-01
Study First Received: March 26, 2012
Last Updated: March 6, 2014
Health Authority: Denmark: The Danish National Committee on Biomedical Research Ethics
Germany: Federal Institute for Drugs and Medical Devices
United Kingdom: National Health Service

Additional relevant MeSH terms:
Venous Insufficiency
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on October 22, 2014