Varicose VeinsMOCASSNCT04441957
MechanO-Chemical Ablation Versus CompreSSion
An observational study of Varicose Veins and Surgery, run by Belarusian State Medical University at 1 site in Belarus.
Trial summary
This study will be looking at the effect of Endovenous Mechano-Chemical Ablation (MOCA) in addition to multilayer elastic compression bandaging vs multilayer elastic compression bandaging only in patients with incompetent great saphenous vein (GSV) and venous ulcers (VU's). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Varicose Veins, Surgery
- What is being tested?
- Endovenous Mechano- Chemical Ablation
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 1 siteBelarus
- Study dates
- 1 Jan 2018to 31 Dec 2021
- Phase
- Observational
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with GSV incompetence and C6 were included in in the prospective consecutive case study if they satisfied the selection criteria.
Who may be able to join
- Patient age > 18 years.
- Current leg ulceration of greater than 6 weeks.
- Great saphenous vein (GSV) incompetence with reflux at least down to the knee level.
- Primary symptomatic varicose veins, Clinical Etiological Anatomical Pathophysiological (CEAP) classification, clinical class C6.
- Able to give informed consent to participate in the study after reading the patient information documentation.
- Ankle Brachial Pressure Index (ABPI) ≥ 0.8.
Who cannot join
- Postoperative varicose veins disease recurrence.
- Patients who are unable to tolerate any multilayer compression bandaging / stockings will be excluded.
- Deep venous thrombosis, thrombophilia associated with a high risk of deep venous thrombosis or postthrombotic syndrome.
- History of pulmonary embolism or stroke.
- Current anticoagulation therapy (within 7 days of enrollment).
- Pregnant or lactating women.
Trial locations and contacts
1 site in 1 country.
Belarus1 site, 1 recruiting
- Recruiting
Educational Institution "Belarusian State Medical University"
Minsk, Dzerzhinski Ave., 83,, 220116
Varvara Boika, + 375 17 277-16-72, intdept@bsmu.by
About this study
Official title: Endovenous MechanO-Chemical Ablation Plus Compression Versus CompreSSion Alone in Chronic Venous Ulcers Treatment
This study will be looking at the effect of Endovenous Mechano-Chemical Ablation (MOCA) in addition to multilayer elastic compression bandaging vs multilayer elastic compression bandaging only in patients with incompetent great saphenous vein (GSV) and venous ulcers (VU's).
Read the detailed description
The most severe form of chronic venous disease is venous ulceration with an overall prevalence of about 1% in the adult population. Venous ulcers significantly impair quality of life, and their treatment places a heavy financial burden upon healthcare systems.
To get the ulcer to heal, the current best treatment is to wear a compression bandage with multiple layers, with which about 60% of these ulcers will heal within 6 months.
There is evidence that treatment of the varicose veins by sahenous veins stripping will prevent the ulcer recurrence.
Recent studies have suggested that novel proceduress of superficial truncal reflux elimination, such as foam sclerotherapy or treating the saphenous veins with termal (laser or radiofrequency) ablation to seal it effectively, may help the ulcers to heal more quickly and increase recurrence-free rate. These techniques can be carried out in the outpatient setting and are much better tolerated by patients in comparison to surgery.
At the same time, no studies which compared compression plus endovenous mechanochemical ablation (MOCA) vs. compression alone in chronic venous ulcers have been conducted to date.
The aim of this study is to see whether treatment of varicose veins using MOCA helps with healing.
- Conditions
- Varicose Veins, Surgery
- Being tested
- Endovenous Mechano- Chemical Ablation
- Keywords
- VV, MOCA, GSV, Venous Ulcers
- Medical subject headings
- Varicose Veins, Varicose Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endovenous Mechano- Chemical AblationDevice
Also called MOCA
The Flebogrif™ catheter (Balton® Sp. z o.o., Warsaw, Poland) represents endoluminal Non Thermal Non Tumescent devices designed to cause occlusion (fibrosis) of the target vein through the combined mechanical and chemical damage to its endothelial lining with retractable cutters and foamed sclerosant.
| Study group | Role | What they receive |
|---|---|---|
| Group A, MOCA-group | Procedure/Surgery: MOCA Mechano-Chemical Ablation plus Elastic Compression Receives: Device: Endovenous Mechano- Chemical Ablation | |
| Group B, Elastic Compression only group | Treatment: Elastic Compression only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with varicose Veins from absent (score 0) to severe (score 3).
None (0), Few, scattered (1), Confined to calf or thigh (2) Involve calf and thigh (3)
Measured: 6-12 months
Number of Participants with skin Pigmentation from absent (score 0) to severe (score 3).
None (0), Limited to perimalleolar area (1), Diffuse over lower third of calf (2), Wider distribution (above lower third of calf) (3)
Measured: 6-12 months
Number of Participants with induration from absent (score 0) to severe (score 3).
None (0), Limited to perimalleolar area (1), Involving lower third of calf (2), Involving more than lower third of calf (3)
Measured: 6-12 months
Number of Participants with active ulcers from absent (score 0) to severe (score 3).
None (0), 1 (1), 2 (2), more than 2 (3)
Measured: 6-12 months
Number of Participants with active ulcer diameter from absent (score 0) to severe (score 3).
None (0), Diameter less than 2 cm (1), Diameter 2-6 cm (2), Diameter more than 6 cm (3)
Measured: 6-12 months
Secondary outcomes (1)
Number of Participants with ulcer recurrence-free rate (no - score 0, yes - score 1)
None (0), Less than 3 months (1), More than 3 months but less than 1 year (2) More than 1year (3)
Measured: 3-24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2020
- Study start1 Jan 2018
- Primary completion15 Jun 2020
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Varicose VeinsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Belarusian State Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Medical University of Warsaw
- Responsible party
- Principal investigator, Vladimir Khryshchanovich, Belarusian State Medical University
- Investigators
- Vladimir MD Khryshchanovich, Prof, Study chair, Educational Institution "Belarusian State Medical University"
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04441957
- Sponsor's protocol ID
- 20140456
- Acronym
- MOCASS
- Status last verified
- Nov 2021
- First submitted
- 19 Jun 2020
- Last updated
- 16 Nov 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: To compare clinical efficacy of Endovenous Mechano-Chemical Ablation (MOCA) in addition to multilayer elastic compression bandaging and multilayer elastic compression bandaging only in patients with incompetent great saphenous vein (GSV) and venous ulcers (VU's).
Publications
Kanchanabat B, Stapanavatr W, Kanchanasuttiruk P. Total superficial vein reflux eradication in the treatment of venous ulcer. World J Surg. 2015 May;39(5):1301-5. doi: 10.1007/s00268-014-2935-y.
PubMed 25680797Barwell JR, Davies CE, Deacon J, Harvey K, Minor J, Sassano A, Taylor M, Usher J, Wakely C, Earnshaw JJ, Heather BP, Mitchell DC, Whyman MR, Poskitt KR. Comparison of surgery and compression with compression alone in chronic venous ulceration (ESCHAR study): randomised controlled trial. Lancet. 2004 Jun 5;363(9424):1854-9. doi: 10.1016/S0140-6736(04)16353-8.
PubMed 15183623Gohel MS, Heatley F, Liu X, Bradbury A, Bulbulia R, Cullum N, Epstein DM, Nyamekye I, Poskitt KR, Renton S, Warwick J, Davies AH; EVRA Trial Investigators. A Randomized Trial of Early Endovenous Ablation in Venous Ulceration. N Engl J Med. 2018 May 31;378(22):2105-2114. doi: 10.1056/NEJMoa1801214. Epub 2018 Apr 24.
PubMed 29688123Sullivan LP, Quach G, Chapman T. Retrograde mechanico-chemical endovenous ablation of infrageniculate great saphenous vein for persistent venous stasis ulcers. Phlebology. 2014 Dec;29(10):654-7. doi: 10.1177/0268355513501301. Epub 2013 Aug 22.
PubMed 23969489Elias S, Raines JK. Mechanochemical tumescentless endovenous ablation: final results of the initial clinical trial. Phlebology. 2012 Mar;27(2):67-72. doi: 10.1258/phleb.2011.010100. Epub 2011 Jul 29.
PubMed 21803800
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endovenous MechanO-Chemical Ablation Plus Compression Versus CompreSSion Alone in Chronic Venous Ulcers Treatment
- ClinicalTrials.gov ID
- NCT04441957
- Acronym / sponsor ID
- MOCASS / 20140456
- Conditions
- Varicose Veins, Surgery
- Keywords
- VV, MOCA, GSV, Venous Ulcers
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Belarusian State Medical UniversityUniversity, hospital or other
- Collaborators
- Medical University of Warsaw
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 15 Jun 2020 (actual)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 22 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will be looking at the effect of Endovenous Mechano-Chemical Ablation (MOCA) in addition to multilayer elastic compression bandaging vs multilayer elastic compression bandaging only in patients with incompetent great saphenous vein (GSV) and venous ulcers (VU's).
Detailed description
The most severe form of chronic venous disease is venous ulceration with an overall prevalence of about 1% in the adult population. Venous ulcers significantly impair quality of life, and their treatment places a heavy financial burden upon healthcare systems.
To get the ulcer to heal, the current best treatment is to wear a compression bandage with multiple layers, with which about 60% of these ulcers will heal within 6 months.
There is evidence that treatment of the varicose veins by sahenous veins stripping will prevent the ulcer recurrence.
Recent studies have suggested that novel proceduress of superficial truncal reflux elimination, such as foam sclerotherapy or treating the saphenous veins with termal (laser or radiofrequency) ablation to seal it effectively, may help the ulcers to heal more quickly and increase recurrence-free rate. These techniques can be carried out in the outpatient setting and are much better tolerated by patients in comparison to surgery.
At the same time, no studies which compared compression plus endovenous mechanochemical ablation (MOCA) vs. compression alone in chronic venous ulcers have been conducted to date.
The aim of this study is to see whether treatment of varicose veins using MOCA helps with healing.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A, MOCA-group | – | Device: Endovenous Mechano- Chemical AblationProcedure/Surgery: MOCA Mechano-Chemical Ablation plus Elastic Compression |
| Group B, Elastic Compression only group | – | –Treatment: Elastic Compression only |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with GSV incompetence and C6 were included in in the prospective consecutive case study if they satisfied the selection criteria.
Key inclusion criteria (6 listed)
- Patient age > 18 years.
- Current leg ulceration of greater than 6 weeks.
- Great saphenous vein (GSV) incompetence with reflux at least down to the knee level.
- Primary symptomatic varicose veins, Clinical Etiological Anatomical Pathophysiological (CEAP) classification, clinical class C6.
- Able to give informed consent to participate in the study after reading the patient information documentation.
Key exclusion criteria (6 listed)
- Postoperative varicose veins disease recurrence.
- Patients who are unable to tolerate any multilayer compression bandaging / stockings will be excluded.
- Deep venous thrombosis, thrombophilia associated with a high risk of deep venous thrombosis or postthrombotic syndrome.
- History of pulmonary embolism or stroke.
- Current anticoagulation therapy (within 7 days of enrollment).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endovenous Mechano- Chemical AblationAlso: MOCAThe Flebogrif™ catheter (Balton® Sp. z o.o., Warsaw, Poland) represents endoluminal Non Thermal Non Tumescent devices designed to cause occlusion (fibrosis) of the target vein through the combined mechanical and chemical damage to its endothelial lining with retractable cutters and foamed sclerosant. | Device | Group A, MOCA-group |
Primary outcome
Number of Participants with varicose Veins from absent (score 0) to severe (score 3).
Time frame: 6-12 months
None (0), Few, scattered (1), Confined to calf or thigh (2) Involve calf and thigh (3)
Number of Participants with skin Pigmentation from absent (score 0) to severe (score 3).
Time frame: 6-12 months
None (0), Limited to perimalleolar area (1), Diffuse over lower third of calf (2), Wider distribution (above lower third of calf) (3)
Number of Participants with induration from absent (score 0) to severe (score 3).
Time frame: 6-12 months
None (0), Limited to perimalleolar area (1), Involving lower third of calf (2), Involving more than lower third of calf (3)
Number of Participants with active ulcers from absent (score 0) to severe (score 3).
Time frame: 6-12 months
None (0), 1 (1), 2 (2), more than 2 (3)
Number of Participants with active ulcer diameter from absent (score 0) to severe (score 3).
Time frame: 6-12 months
None (0), Diameter less than 2 cm (1), Diameter 2-6 cm (2), Diameter more than 6 cm (3)
1 secondary outcome
Number of Participants with ulcer recurrence-free rate (no - score 0, yes - score 1)
Time frame: 3-24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2021.
- Background: PubMed 25680797Kanchanabat B, Stapanavatr W, Kanchanasuttiruk P. Total superficial vein reflux eradication in the treatment of venous ulcer. World J Surg. 2015 May;39(5):1301-5. doi: 10.1007/s00268-014-2935-y.
- Background: PubMed 15183623Barwell JR, Davies CE, Deacon J, Harvey K, Minor J, Sassano A, Taylor M, Usher J, Wakely C, Earnshaw JJ, Heather BP, Mitchell DC, Whyman MR, Poskitt KR. Comparison of surgery and compression with compression alone in chronic venous ulceration (ESCHAR study): randomised controlled trial. Lancet. 2004 Jun 5;363(9424):1854-9. doi: 10.1016/S0140-6736(04)16353-8.
- Background: PubMed 29688123Gohel MS, Heatley F, Liu X, Bradbury A, Bulbulia R, Cullum N, Epstein DM, Nyamekye I, Poskitt KR, Renton S, Warwick J, Davies AH; EVRA Trial Investigators. A Randomized Trial of Early Endovenous Ablation in Venous Ulceration. N Engl J Med. 2018 May 31;378(22):2105-2114. doi: 10.1056/NEJMoa1801214. Epub 2018 Apr 24.
- Background: PubMed 23969489Sullivan LP, Quach G, Chapman T. Retrograde mechanico-chemical endovenous ablation of infrageniculate great saphenous vein for persistent venous stasis ulcers. Phlebology. 2014 Dec;29(10):654-7. doi: 10.1177/0268355513501301. Epub 2013 Aug 22.
- Background: PubMed 21803800Elias S, Raines JK. Mechanochemical tumescentless endovenous ablation: final results of the initial clinical trial. Phlebology. 2012 Mar;27(2):67-72. doi: 10.1258/phleb.2011.010100. Epub 2011 Jul 29.
- Individual participant dataSharing planned: Yes. To compare clinical efficacy of Endovenous Mechano-Chemical Ablation (MOCA) in addition to multilayer elastic compression bandaging and multilayer elastic compression bandaging only in patients with incompetent great saphenous vein (GSV) and venous ulcers (VU's).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vladimir MD Khryshchanovich, Prof study chair
Educational Institution "Belarusian State Medical University"
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Varicose Veins and Surgery, run by Belarusian State Medical University at 1 site in Belarus.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. 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: status not confirmed, as of the sponsor's last update on 16 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belarus. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Vladimir MD Khryshchanovich, Prof (+375296245578, vladimirkh77@mail.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with varicose Veins from absent (score 0) to severe (score 3). (time frame: 6-12 months). The study lists 5 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 NCT04441957, which also lists 5 linked publications.
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 16 Nov 2021.