The Sapheon Closure System Feasibility Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sapheon, Inc.
ClinicalTrials.gov Identifier:
NCT01603433
First received: May 18, 2012
Last updated: September 24, 2014
Last verified: September 2014
  Purpose

This is a single center, prospective, non-randomized, feasibility study for the evaluation of safety, efficacy and performance of the Sapheon™ Closure System for the treatment of incompetent saphenous veins.


Condition
Venous Insufficiency of Leg

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Sapheon Closure System Feasibility Study

Further study details as provided by Sapheon, Inc.:

Primary Outcome Measures:
  • Anatomical Success [ Time Frame: 30 days post procedure ] [ Designated as safety issue: No ]
    Evaluation of anatomic efficacy will be demonstrated by the absence of flow (Complete Closure) within the treated vein segment as determined by duplex ultrasound examination and will be performed in accordance with a standardized and detailed imaging protocol.


Secondary Outcome Measures:
  • Safety Endpoint [ Time Frame: Through 6 month follow-up ] [ Designated as safety issue: Yes ]
    Evaluation of safety will be assessed by the DSMB of all incidence of adverse events (procedure and non-procedure related; serious and non-serious)


Enrollment: 38
Study Start Date: July 2011
Study Completion Date: July 2014
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Detailed Description:

Venous insufficiency of the lower extremities is a very common condition that is influenced by genetic and mechanical factors, and is a chronic and progressive disorder. The primary objectives for this clinical Study are to

  1. demonstrate the safety of the Sapheon™ Closure System for the treatment of incompetent saphenous veins,
  2. demonstrate the early and late efficacy of The Sapheon™ Closure System for the treatment of incompetent saphenous veins, and
  3. demonstrate the satisfactory performance of the Sapheon™ Closure System device components.
  Eligibility

Ages Eligible for Study:   21 Years to 76 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

All patients with venous leg insufficiency presenting themselves at the hospital vein clinic and or physicians office will be evaluated to inclusion.

Criteria

Inclusion Criteria:

  • Males or non-pregnant females ≥21 years of age but <76 years of age.
  • Venous reflux disease in the GSV diagnosed by clinical symptoms, with or without visible varicosities, and confirmed by duplex ultrasound imaging.
  • Candidate for surgical closure of a segment of the GSV.
  • CEAP classification of C2, C3 or C4.
  • Ability to walk unassisted.
  • Life expectancy of at least 18 months.
  • Ability to attend follow-up visits.
  • Ability to understand the investigational nature of the treatment, and to provide written informed consent.

Exclusion Criteria:

  • Previous surgical procedure (surgical, thermal, or chemical ablation) associated with the venous segment to be treated.
  • Diameter of index vein (Supine) <3mm or >12 mm in any segment.
  • Tortuous GSV, which in the opinion of the Investigator will limit catheter placement.
  • Local or systemic infection.
  • Insulin dependent diabetes.
  • Leg obesity impairing the ability to gain access to the treatment leg, and/or apply sufficient compression for treatment.
  • Documented history of superficial or deep thrombophlebitis.
  • Varicosities secondary to pelvic or abdominal tumor.
  • Significant arterial insufficiency; demonstrated by absence of ankle pulse.
  • Known sensitivity to the cyanoacrylate (CA) adhesive or positive reaction just prior to surgery (by injecting a small peripheral vein with the agent). The Study surgeon will judge the need for the injection and the subject's reaction to the injection on clinical grounds.
  • Formal duplication of the saphenous trunk in the index vein (Accessory GSV segments allowed).
  • Hypercoaguable state.
  • Presence of incompetent perforators in the treatment length.
  • History of right ventricular failure.
  • Significant femoral or popliteal vein insufficiency.
  • Additional procedures in the treatment leg likely required within the six months after the investigational procedure.
  • Current participation in another clinical study involving an investigational agent or treatment, or within the 30 days prior to enrollment.
  • Other concurrent medical or other condition (chronic or acute in nature) that in the opinion of the Investigator may prevent safe participation or otherwise render the subject ineligible for the Study.
  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: NCT01603433

Locations
Dominican Republic
Clinica Canela
Santo Domingo, Dominican Republic
Sponsors and Collaborators
Sapheon, Inc.
Investigators
Principal Investigator: Claudia Bautista, MD Clinica Canela
  More Information

No publications provided

Responsible Party: Sapheon, Inc.
ClinicalTrials.gov Identifier: NCT01603433     History of Changes
Other Study ID Numbers: CP-10669-01
Study First Received: May 18, 2012
Last Updated: September 24, 2014
Health Authority: Dominican Republic: Consejo Nacional de Bioetica en Salud
Dominican Republic: Secretaría del Estado de Salud Pública y Asistencia Social (SESPAS)

Additional relevant MeSH terms:
Venous Insufficiency
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on October 29, 2014