NCT01972633

Brief Summary

There is a difference concerning obliteration rate and postoperative pain after treatment of the saphenous vein with 1470nm laser or VNUS Closure Fast (=radiofrequency method) .

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
140

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jun 2010

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

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

June 1, 2010

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

December 4, 2012

Completed
11 months until next milestone

First Posted

Study publicly available on registry

October 30, 2013

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
Last Updated

October 30, 2013

Status Verified

October 1, 2013

Enrollment Period

3.8 years

First QC Date

December 4, 2012

Last Update Submit

October 24, 2013

Conditions

Venous Insufficiency

Keywords

endovenous treatmentLaser, Vnus Closure FastVaricosisgreat saphenous veinsmall saphenous veinVenous Insufficiency

Outcome Measures

Primary Outcomes (1)

  • Pain

    Pain (visual analogue scale) on the day of treatment

    day 0

Secondary Outcomes (2)

  • Obliteration of the treated vein (GSV or SSV)

    day 10, month 3, month 12

  • Patient´s satisfaction after the intervention

    day 10, month 3, month 12

Other Outcomes (1)

  • paresthesia of the lower leg after intervention

    day 10, month 3, month 12

Study Arms (2)

1470nm Laser

ACTIVE COMPARATOR

Patient with varicose vein treated with 1470nm Laser (Biolitec)

Procedure: LaserProcedure: Radiofrequency

VNUS Closure Fast

ACTIVE COMPARATOR

Patient with varicose vein treated with VNUS Closure Fast (Radiofrequency System)

Procedure: LaserProcedure: Radiofrequency

Interventions

LaserPROCEDURE

Endovenous Laser (1470nm) ablation of great or small saphenous vein

1470nm LaserVNUS Closure Fast
RadiofrequencyPROCEDURE

Endovenous Radiofrequency (VNUS Closure Fast) of great or small saphenous vein

1470nm LaserVNUS Closure Fast

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • varicosis of great saphenous vein Hach-classification II-III (CEAP-classification: C3-4EPAS2-3PR and/or varicosis of small saphenous vein der Hach-classification I-III CEAP-classification: C3-4EPAS4PR)
  • maximum diameter of the great saphenous vein of 15mm maximum diameter of the small saphenous vein of 12mm

You may not qualify if:

  • surgical treatment of the saphenous vein in the past
  • sclerotherapy of the saphenous vein in the past
  • phlebitis or thrombosis of the saphenous vein
  • surgical treatment of an venous ulcer in the past
  • postthrombotic syndrome
  • erysipelas of the leg in the past
  • chronic treatment with pain-killers or chronic alcoholism
  • pregnancy
  • drug allergy against painkillers that are used in this study
  • spinal anesthesia not possible
  • compression bandage not possible
  • patients with polyneuropathy
  • patients with chronic pain
  • persons that do have a connection or persons that are working for one of the jused companies (Laser or VNUS Closure Fast)
  • participation on an other clinical trial that can interfere with this clinical trial
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

2.Chirurgische Abteilung AKh Linz GesmbH

Linz, Upper Austria, 4020, Austria

RECRUITING

MeSH Terms

Conditions

Venous Insufficiency

Interventions

Lasers

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Optical DevicesEquipment and SuppliesRadiation Equipment and Supplies

Study Officials

  • Markus Schreiner

    2.Chirurgische Abteilung AKh Linz GesmbH

    PRINCIPAL INVESTIGATOR

  • Andreas Shamiyeh

    2. Chirurgische Abteilung AKh Linz GesmbH

    STUDY CHAIR

Central Study Contacts

Markus Schreiner

CONTACT

0043 732 7806 73295office@chirurgie-schreiner.at

Andreas Shamiyeh

CONTACT

0043 732 7806 2133andreas.shamiyeh@akh.linz.at

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Oberarzt

Study Record Dates

First Submitted

December 4, 2012

First Posted

October 30, 2013

Study Start

June 1, 2010

Primary Completion

March 1, 2014

Study Completion

April 1, 2014

Last Updated

October 30, 2013

Record last verified: 2013-10

Locations

AU(1)