NCT01603433

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2011

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2011

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

May 18, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 22, 2012

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
Last Updated

May 3, 2016

Status Verified

April 1, 2016

Enrollment Period

1 year

First QC Date

May 18, 2012

Last Update Submit

April 29, 2016

Conditions

Venous Insufficiency of Leg

Outcome Measures

Primary Outcomes (1)

  • Anatomical Success

    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.

    30 days post procedure

Secondary Outcomes (1)

  • Safety Endpoint

    Through 6 month follow-up

Study Arms (1)

Sapheon™ Closure System

EXPERIMENTAL

Sapheon™ Closure System for the treatment of incompetent saphenous veins.

Device: Sapheon™ Closure System

Interventions

Sapheon™ Closure SystemDEVICE

Sapheon™ Closure System for the treatment of incompetent saphenous veins.

Sapheon™ Closure System

Eligibility Criteria

Age21 Years - 76 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • Weight \>110 lbs. (50 kg).
  • Ability to attend follow-up visits.
  • Ability to understand the investigational nature of the treatment, and to provide written informed consent.

You may not qualify if:

  • 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.
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinica Canela

Santo Domingo, Dominican Republic

Location

Related Publications (1)

  • Almeida JI, Javier JJ, Mackay EG, Bautista C, Cher DJ, Proebstle TM. Two-year follow-up of first human use of cyanoacrylate adhesive for treatment of saphenous vein incompetence. Phlebology. 2015 Jul;30(6):397-404. doi: 10.1177/0268355514532455. Epub 2014 Apr 30.

    PMID: 24789750DERIVED

Study Officials

  • Claudia Bautista, MD

    Clinica Canela

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 18, 2012

First Posted

May 22, 2012

Study Start

July 1, 2011

Primary Completion

July 1, 2012

Study Completion

July 1, 2014

Last Updated

May 3, 2016

Record last verified: 2016-04

Data Sharing

IPD Sharing
Will not share

Locations

DO(1)