Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

EVLA and Optimal Timing of Sclerotherapy (FinnTrunk)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04774939
Recruitment Status : Not yet recruiting
First Posted : March 1, 2021
Last Update Posted : March 1, 2021
Sponsor:
Collaborators:
Helsinki University Central Hospital
Oulu University Hospital
Tampere University Hospital
Päijänne Tavastia Central Hospital
Satasairaala
Vaasa Central Hospital, Vaasa, Finland
Information provided by (Responsible Party):
Khalil Firoozi, Turku University Hospital

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
The aim of the study is to investigate the optimal timing of sclerotherapy for treatment of varicose tributaries on EVLA (endogenous laser ablation) patients.

Condition or disease Intervention/treatment Phase
Venous Reflux Procedure: Endovenous laser ablation Not Applicable

Detailed Description:

The study inclusion criteria is patients with main trunk (VSM, SSV, AASV) reflux to be treated with EVLA, suffering C2-C3 varicose disease, age 18-years and no severe co-morbidities.

Patients with written consent will be randomized to two primary treatments groups; EVLA only and EVLA combined with sclerotherapy of varicose tributaries. The primary outcome is the requirement additional sclerotherapy on 3 month control visit. Other study outcomes are pain, quality of life (veins questionnaire), severity score and also recurring of varicose disease at 1, 3 and 5 years.

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 350 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: FinnTrunk, EVLA and Optimal Timing of Sclerotherapy
Estimated Study Start Date : March 15, 2021
Estimated Primary Completion Date : March 15, 2027
Estimated Study Completion Date : March 15, 2030
Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Active Comparator: EVLA only
Only main trunk/trunks with venous reflux will be treated
 Procedure: Endovenous laser ablation
The aim is to combine the significance of for sclerotherapy at the primary EVLA treatment
Other Name: Endovenous laser ablation combined with foam sclerotherapy of varicose tributaries
Active Comparator: EVLA and sclerotherapy of tributaries
Main trunk/trunks with venous reflux will be treated combined with foam sclerotherapy
 Procedure: Endovenous laser ablation
The aim is to combine the significance of for sclerotherapy at the primary EVLA treatment
Other Name: Endovenous laser ablation combined with foam sclerotherapy of varicose tributaries


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. re-intervention [ Time Frame: 3 months ]
    Requirement of re-intervention

  2. Pain after procedure [ Time Frame: up to 3 months after the treatment ]
    Post procedural pain measured with VAS scale

  3. Quality of life before after procedure [ Time Frame: up to 5 years ]
    Quality of life will be measured with Veins questionnaire

  4. Recur [ Time Frame: up to 5 years ]
    The recurring varicose veins


Secondary Outcome Measures :
  1. Surgical complications [ Time Frame: 3 months ]
    Infections, DVT, Pulmonary embolus will be reported


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Varicose disease of lower extremity caused by reflux of VSM, SSV or AASV to be treated with EVLA. Age over 18 years. Clinical symptoms C2-3.

Exclusion Criteria:

  • No severe comorbidities. Previous DVT.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04774939


Contacts
Layout table for location contacts
Contact: Harri Hakovirta, Professor +358405918811 haheha@utu.fi
Contact: Khalil Firoozi, MD +35823130000 khalil.firoozi@tyks.fi

Locations
Layout table for location information
Finland
Turku University Hospital
Turku, Finland, 20520
Contact: Harri Hakovirta, Professor    +35823130000    harri.hakovirta@tyks.fi   
Contact: Khalil Firoozi, MD    +35823130000    khalil.firoozi@tyks.fi   
Sub-Investigator: Jaakko Viljamaa, MD         
Sponsors and Collaborators
Turku University Hospital
Helsinki University Central Hospital
Oulu University Hospital
Tampere University Hospital
Päijänne Tavastia Central Hospital
Satasairaala
Vaasa Central Hospital, Vaasa, Finland
Investigators
Layout table for investigator information
Study Chair: Harri Hakovirta, Professor University of Turku
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Khalil Firoozi, MD, Turku University Hospital
ClinicalTrials.gov Identifier: NCT04774939    
Other Study ID Numbers: 93 /1801/2020
First Posted: March 1, 2021    Key Record Dates
Last Update Posted: March 1, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No