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Chronic Venous Insufficiency, CVIPOLFLEBNCT04558957

Clinical Study to Assess the Safety and Efficacy of Mechanochemical Ablation With Flebogrif in Patients With Great Saphenous Vein Insufficiency

A study testing FLEBOGRIF in people with Chronic Venous Insufficiency, CVI, run by Balton Sp.zo.o. at 4 sites in Poland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The objective of the study is to collect clinical data of patients in whom Flebogrif® will have been used for mechanochemical ablation of incompetent veins in the follow-up period, as related to the safety, clinical effectiveness, properties and advantages of Flebogrif®. Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Chronic Venous Insufficiency, CVI
What is being tested?
FLEBOGRIF
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
4 sitesPoland
Study dates
8 Aug 2019to 28 Apr 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study inclusion criteria:

  1. Signing the Informed Consent Form by the patient found eligible for the treatment with the mechanochemical method
  2. The patient declares willingness to participate in the study and in the monitoring visits envisaged in the study protocol
  3. A patient with diagnosed varicose veins and diagnosed great saphenous vein (GSV) insufficiency confirmed by ultrasound (CEAP class C2-C6)
  4. Favourable anatomy enabling the introduction of the Flebogrif® guidewire/catheter and positioning of its top part at the dedicated site (2-3 cm below SFJ)
  5. Diameter of the treated vein of 4-10 mm
  6. No data or no history indicating an allergy to the sclerosing chemicals used in the mechanochemical method (polidocanol), on the basis of the information obtained from the patient and the available medical records
  7. No clinical symptoms indicating (chronic, critical) lower limb ischaemia precluding the use of compression, on the basis of a physical examination or, in unclear cases, of a Doppler ultrasound examination
  8. No medical information or no history of coagulation system dysfunction of the type of thrombophilia or bleeding diatheses
  9. No cutaneous lesions (purulent, bullous) within the limb found eligible for treatment with the mechanochemical method
  10. No clinical data indicating recent thrombosis within the deep vein system
  11. No clinical data on diabetes with vascular complications
  12. No clinical data indicating an active neoplastic process

Study exclusion criteria:

  1. Recent deep vein thrombosis or occlusion
  2. Congenital disorders with associated occlusion of deep system veins
  3. Pregnancy and breast-feeding
  4. Lower limb ischaemia
  5. Severe lymphatic oedema
  6. Bleeding diatheses
  7. Documented allergic reaction to sclerosing chemicals used in mechanochemical vein ablation
  8. Purulent dermatoses affecting the limb found eligible for treatment with mechanochemical vein ablation
  9. Previous procedures on insufficiency veins of the superficial system
  10. Acute infection
  11. History of great saphenous vein thrombosis
  12. End-stage kidney disease

Trial locations and contacts

4 sites in 1 country.

Poland4 sites

  • Centrum Chirurgii i Stomatologii Jaworuccy Sp. P.

    Gorzów Wielkopolski, 66-400

  • Centrum Medyczne Angelius Provita; Europejskie Centrum Flebologii

    Katowice, 40-611

  • Medyczne Centrum Nałęczów sp. z o.o.

    Lublin, 20-950

  • Klinika Dorobisz

    Wroclaw, 54-130

Other trials in Poland

About this study

Official title: Prospective, Multi-centre Clinical Study to Assess the Safety and Efficacy of Mechanochemical Ablation With the Use of Flebogrif in Patients With Great Saphenous Vein Insufficiency

The objective of the study is to collect clinical data of patients in whom Flebogrif® will have been used for mechanochemical ablation of incompetent veins in the follow-up period, as related to the safety, clinical effectiveness, properties and advantages of Flebogrif®.

The proposed study is a prospective, multi-centre clinical trial assessing the safety, efficacy and quality of Flebogrif® in a population of patients with the incompetent great saphenous vein, who require surgical treatment.

Being tested
FLEBOGRIF
Medical subject headings
Blindness, Cortical

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FLEBOGRIFDevice

    The catheter is a device dedicated to mechano-chemical ablation of insufficient veins of the superficial system.

Study groups in NCT04558957
Study groupRoleWhat they receive
FLEBOGRIFExperimentalInterventions will be performed using Flebogrif catheter.
Receives: Device: FLEBOGRIF

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Primary efficacy endpoint: Occlusion rate

    Primary efficacy endpoint: Occlusion rate of the great saphenous vein in the treated segment at 3 months

    Measured: 3 months

  2. Primary safety endpoint: Rate of SAE

    Primary safety endpoint: Rate of serious adverse events within 30 days after the procedure

    Measured: 30 days after the procedure

Secondary outcomes (10)

  1. Occlusion rate

    Occlusion rate of the great saphenous vein at 1, 6, 12, 18 and 24 months

    Measured: 1, 6, 12, 18, 24 months

  2. Number of Participants with no reflux in treated segment of the vein

    Number of Participants with no reflux in the treated segment of the great saphenous vein at 1, 3, 6, 12, 18 and 24 months

    Measured: 1, 3, 6, 12, 18, 24 months

  3. Change in quality of life by Aberdeen Varicose Vein Questionnaire

    Change in quality of life measured with the use of the Aberdeen Varicose Vein Questionnaire at 12 and 24 months

    Scale score: 0-100; higher score = worse outcome.

    Measured: 12 and 24 months

  4. Clinical success - changes in rVCSS

    Clinical success, defined as change in rVCSS classification (Revised Venous Clinical Severity Score) after 12 and 24 months

    Scale score 0-30; higher score = worse outcome.

    Measured: 12 and 24 months

  5. Assessment of pain during the procedure

    Assessment of pain during the procedure (Visual Analogue Pain Scale, VAPS) ranging from 0 to 10. Pain assessed using the Visual Analogue Scale (range 0-10; 0 = no pain; 2 = mild pain, 4 = nagging, annoying pain; 6 = severe pain; 8 = very severe pain; 10 = unbearable pain).

    Measured: During procedure

  6. Assessment of pain within 0-7 days after the procedure: Visual Analogue Scale

    Assessment of pain within 0-7 days after the procedure (VAPS 0-10, daily assessment). Pain assessed using the Visual Analogue Scale (range 0-10; 0 = no pain; 2 = mild pain, 4 = nagging, annoying pain; 6 = severe pain; 8 = very severe pain; 10 = unbearable pain).

    Measured: 0-7 days after procedure

  7. Assessment of the need for analgesic treatment

    Assessment of the need for analgesic treatment after the procedure (0-7 days)

    Measured: 0-7 days after procedure

  8. Period needed to resume normal activities

    Period needed to resume normal activities

    Measured: up to 2 years after the treatment

  9. Period needed to return to work (sick leave period)

    Period needed to return to work (sick leave period)

    Measured: up to 2 years after the treatment

  10. Complications rate

    Complications rate including deep vein thrombosis, nerve damage, infections, etc.

    Measured: up to 2 years after the treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Sep 2020
  2. Study start8 Aug 2019
  3. Primary completion12 Aug 2021
  4. Study completion28 Apr 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
200 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04558957
Sponsor's protocol ID
POLFLEB
Acronym
POLFLEB
Status last verified
Jun 2023
First submitted
16 Sep 2020
Last updated
18 Jun 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Zubilewicz T, Urbanek T, Janczak D, Jaworucka A, Terlecki K, Ilzecki M, Dorobisz T, Jusko M, Hawro P, Terlecki P. The prospective multicenter study assessing safety and efficacy of mechano-chemical ablation with the use of the Flebogrif catheter in patients with Great Saphenous Vein incompetence: one year results. J Vasc Surg Venous Lymphat Disord. 2026 Jul 30:102584. doi: 10.1016/j.jvsv.2026.102584. Online ahead of print.

    PubMed 42532411

Questions about this trial

What is this clinical trial studying?

A study testing FLEBOGRIF in people with Chronic Venous Insufficiency, CVI, run by Balton Sp.zo.o. at 4 sites in Poland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Primary efficacy endpoint: Occlusion rate (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04558957, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2023.

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