NCT01459263

Brief Summary

More than 25 percent of the general population suffers from varicose veins, which has a considerable impact on quality of life. Nowadays endovenous treatment modalities for great saphenous incompetence are widely accepted. Mechanochemical endovenous ablation is a new tumescent-less technique, that combines mechanical endothelial damage using a rotating wire with the infusion of a liquid sclerosant. The current study aims at evaluating short and long term outcome after mechanochemical endovenous ablation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
124

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2010

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

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

November 1, 2010

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

August 8, 2011

Completed
3 months until next milestone

First Posted

Study publicly available on registry

October 25, 2011

Completed
6.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2018

Completed
Last Updated

April 26, 2018

Status Verified

April 1, 2018

Enrollment Period

7.3 years

First QC Date

August 8, 2011

Last Update Submit

April 25, 2018

Conditions

Varicosis

Keywords

GSVinsufficiencyClariVein devicesafetyefficacyQOL

Outcome Measures

Primary Outcomes (1)

  • Occlusion rate

    The percentage of GSV occluded

    30 days, 1, 2, and 5 years

Secondary Outcomes (7)

  • Health status

    30 days, 1, 2, and 5 years

  • Disease related quality of life

    30 days, 1, 2, and 5 years

  • Pain score during procedure

    peri-procedural

  • 2-weeks post-procedure pain score

    two weeks

  • recovery time

    two weeks

  • +2 more secondary outcomes

Study Arms (1)

GSV insufficiency

Patients with insufficiency of the greater saphenous vein (GSV) will be included.

Device: ClariVein

Interventions

ClariVeinDEVICE

Using the ClariVein device, the GSV will be occluded.

GSV insufficiency

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with insufficiency of the greater saphenous vein will be included.

You may qualify if:

  • Insufficiency of the GSV
  • Ultrasound criteria for endovenous treatment have been met:
  • Diameter GSV between 3-12 mm
  • No thrombus present at the GSV part to be treated
  • Signed informed consent
  • Patient willing to present at follow-up visits
  • Age \> 18 jaar

You may not qualify if:

  • Patient is unable to give informed consent
  • Patient unable to present at all follow-up visits
  • Other treatment is more suitable for the treatment of the varicose veins than mechano-chemical ablation
  • Pregnancy and breast feeding
  • Known allergy/ contra indication for sclerotherapy
  • Previous ipsilateral surgical treatment of varicose veins
  • Deep venous vein thrombosis in medical history
  • Anticoagulant therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Rijnstate Hospital

Arnhem, Gelderland, Netherlands

Location

St. Antonius Hospital

Nieuwegein, Netherlands

Location

Related Publications (4)

  • van Eekeren RR, Boersma D, Elias S, Holewijn S, Werson DA, de Vries JP, Reijnen MM. Endovenous mechanochemical ablation of great saphenous vein incompetence using the ClariVein device: a safety study. J Endovasc Ther. 2011 Jun;18(3):328-34. doi: 10.1583/11-3394.1.

    PMID: 21679070RESULT

  • van Eekeren RR, Boersma D, de Vries JP, Reijnen MM. [Endovenous mechanochemical ablation for varicose veins--a new endovenous technique without tumescent anaesthesia]. Ned Tijdschr Geneeskd. 2011;155(33):A3177. Dutch.

    PMID: 21854655RESULT

  • van Eekeren RR, Boersma D, Konijn V, de Vries JP, Reijnen MM. Postoperative pain and early quality of life after radiofrequency ablation and mechanochemical endovenous ablation of incompetent great saphenous veins. J Vasc Surg. 2013 Feb;57(2):445-50. doi: 10.1016/j.jvs.2012.07.049. Epub 2012 Nov 8.

    PMID: 23141679RESULT

  • Boersma D, van Eekeren RR, Werson DA, van der Waal RI, Reijnen MM, de Vries JP. Mechanochemical endovenous ablation of small saphenous vein insufficiency using the ClariVein((R)) device: one-year results of a prospective series. Eur J Vasc Endovasc Surg. 2013 Mar;45(3):299-303. doi: 10.1016/j.ejvs.2012.12.004. Epub 2013 Jan 9.

    PMID: 23312507RESULT

Study Officials

  • Michel MJ Reijnen, MD, PhD

    Rijnstate Hospital

    PRINCIPAL INVESTIGATOR

  • Jean-Paul Vries, de, MD, Phd

    St. Antonius Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

August 8, 2011

First Posted

October 25, 2011

Study Start

November 1, 2010

Primary Completion

February 1, 2018

Study Completion

February 1, 2018

Last Updated

April 26, 2018

Record last verified: 2018-04

Locations

NL(2)