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NCT Number: NCT04558957

Clinical Study to Assess the Safety and Efficacy of Mechanochemical Ablation With 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.

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Key information

Conditions

Chronic Venous Insufficiency, CVI Blindness Blindness, Cortical Eye Diseases Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms Vision Disorders

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centrum Chirurgii i Stomatologii Jaworuccy Sp. P., Gorzów Wielkopolski, Poland

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Study inclusion criteria:

  • Signing the Informed Consent Form by the patient found eligible for the treatment with the mechanochemical method
  • The patient declares willingness to participate in the study and in the monitoring visits envisaged in the study protocol
  • A patient with diagnosed varicose veins and diagnosed great saphenous vein (GSV) insufficiency confirmed by ultrasound (CEAP class C2-C6)
  • 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)
  • Diameter of the treated vein of 4-10 mm
  • 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
  • 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
  • No medical information or no history of coagulation system dysfunction of the type of thrombophilia or bleeding diatheses
  • No cutaneous lesions (purulent, bullous) within the limb found eligible for treatment with the mechanochemical method
  • No clinical data indicating recent thrombosis within the deep vein system
  • No clinical data on diabetes with vascular complications
  • No clinical data indicating an active neoplastic process

Study exclusion criteria:

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

Treatment and study plan

Flebogrif

Device

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

Primary outcomes

  1. Primary efficacy endpoint: Occlusion rate

    Time frame: 3 months

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

  2. Primary safety endpoint: Rate of SAE

    Time frame: 30 days after the procedure

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

Secondary outcomes

  1. Occlusion rate

    Time frame: 1, 6, 12, 18, 24 months

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

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

    Time frame: 1, 3, 6, 12, 18, 24 months

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

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

    Time frame: 12 and 24 months

    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.

  4. Clinical success - changes in rVCSS

    Time frame: 12 and 24 months

    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.

  5. Assessment of pain during the procedure

    Time frame: During 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).

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

    Time frame: 0-7 days after procedure

    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).

  7. Assessment of the need for analgesic treatment

    Time frame: 0-7 days after procedure

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

  8. Period needed to resume normal activities

    Time frame: up to 2 years after the treatment

    Period needed to resume normal activities

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

    Time frame: up to 2 years after the treatment

    Period needed to return to work (sick leave period)

  10. Complications rate

    Time frame: up to 2 years after the treatment

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

Sponsors and collaborators

Lead sponsor

Balton Sp.zo.o.

Industry

Collaborators

  • KCRI

Registry information

Official study 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

Acronym: POLFLEB

Important dates

Study start
2019
Primary completion
2021
Study completion
2023
First posted
Sep 22, 2020
Registry last updated
Jun 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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