Back to resultsClinical Study to Assess the Safety and Efficacy of Mechanochemical Ablation With Flebogrif in Patients With Great Saphenous Vein Insufficiency (POLFLEB)
Primary Purpose
Chronic Venous Insufficiency, CVI
Status
Completed
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
FLEBOGRIF
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Venous Insufficiency, CVI
Eligibility Criteria
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
Sites / Locations
- Centrum Chirurgii i Stomatologii Jaworuccy Sp. P.
- Centrum Medyczne Angelius Provita; Europejskie Centrum Flebologii
- Medyczne Centrum Nałęczów sp. z o.o.
- Klinika Dorobisz
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
FLEBOGRIF
Arm Description
Interventions will be performed using Flebogrif catheter.
Outcomes
Primary Outcome Measures
Primary efficacy endpoint: Occlusion rate
Primary efficacy endpoint: Occlusion rate of the great saphenous vein in the treated segment at 3 months
Primary safety endpoint: Rate of SAE
Primary safety endpoint: Rate of serious adverse events within 30 days after the procedure
Secondary Outcome Measures
Occlusion rate
Occlusion rate of the great saphenous vein at 1, 6, 12, 18 and 24 months
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
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.
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.
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).
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).
Assessment of the need for analgesic treatment
Assessment of the need for analgesic treatment after the procedure (0-7 days)
Period needed to resume normal activities
Period needed to resume normal activities
Period needed to return to work (sick leave period)
Period needed to return to work (sick leave period)
Complications rate
Complications rate including deep vein thrombosis, nerve damage, infections, etc.
Full Information
NCT ID
NCT04558957
First Posted
September 16, 2020
Last Updated
June 15, 2023
Sponsor
Balton Sp.zo.o.
Collaborators
KCRI
1. Study Identification
Unique Protocol Identification Number
NCT04558957
Brief Title
Clinical Study to Assess the Safety and Efficacy of Mechanochemical Ablation With Flebogrif in Patients With Great Saphenous Vein Insufficiency
Acronym
POLFLEB
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
August 8, 2019 (Actual)
Primary Completion Date
August 12, 2021 (Actual)
Study Completion Date
April 28, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Balton Sp.zo.o.
Collaborators
KCRI
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief 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®.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Venous Insufficiency, CVI
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
200 (Actual)
8. Arms, Groups, and Interventions
Arm Title
FLEBOGRIF
Arm Type
Experimental
Arm Description
Interventions will be performed using Flebogrif catheter.
Intervention Type
Device
Intervention Name(s)
FLEBOGRIF
Intervention Description
The catheter is a device dedicated to mechano-chemical ablation of insufficient veins of the superficial system.
Primary Outcome Measure Information:
Title
Primary efficacy endpoint: Occlusion rate
Description
Primary efficacy endpoint: Occlusion rate of the great saphenous vein in the treated segment at 3 months
Time Frame
3 months
Title
Primary safety endpoint: Rate of SAE
Description
Primary safety endpoint: Rate of serious adverse events within 30 days after the procedure
Time Frame
30 days after the procedure
Secondary Outcome Measure Information:
Title
Occlusion rate
Description
Occlusion rate of the great saphenous vein at 1, 6, 12, 18 and 24 months
Time Frame
1, 6, 12, 18, 24 months
Title
Number of Participants with no reflux in treated segment of the vein
Description
Number of Participants with no reflux in the treated segment of the great saphenous vein at 1, 3, 6, 12, 18 and 24 months
Time Frame
1, 3, 6, 12, 18, 24 months
Title
Change in quality of life by Aberdeen Varicose Vein Questionnaire
Description
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.
Time Frame
12 and 24 months
Title
Clinical success - changes in rVCSS
Description
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.
Time Frame
12 and 24 months
Title
Assessment of pain during the procedure
Description
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).
Time Frame
During procedure
Title
Assessment of pain within 0-7 days after the procedure: Visual Analogue Scale
Description
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).
Time Frame
0-7 days after procedure
Title
Assessment of the need for analgesic treatment
Description
Assessment of the need for analgesic treatment after the procedure (0-7 days)
Time Frame
0-7 days after procedure
Title
Period needed to resume normal activities
Description
Period needed to resume normal activities
Time Frame
up to 2 years after the treatment
Title
Period needed to return to work (sick leave period)
Description
Period needed to return to work (sick leave period)
Time Frame
up to 2 years after the treatment
Title
Complications rate
Description
Complications rate including deep vein thrombosis, nerve damage, infections, etc.
Time Frame
up to 2 years after the treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Centrum Chirurgii i Stomatologii Jaworuccy Sp. P.
City
Gorzów Wielkopolski
ZIP/Postal Code
66-400
Country
Poland
Facility Name
Centrum Medyczne Angelius Provita; Europejskie Centrum Flebologii
City
Katowice
ZIP/Postal Code
40-611
Country
Poland
Facility Name
Medyczne Centrum Nałęczów sp. z o.o.
City
Lublin
ZIP/Postal Code
20-950
Country
Poland
Facility Name
Klinika Dorobisz
City
Wrocław
ZIP/Postal Code
54-130
Country
Poland
12. IPD Sharing Statement
Learn more about this trial
Clinical Study to Assess the Safety and Efficacy of Mechanochemical Ablation With Flebogrif in Patients With Great Saphenous Vein Insufficiency
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