Varicose Veins of Lower LimbNCT06387264
Compont - Varicose Veins of the Lower Extremities
A study testing Medical Adhesive and ClosureFast Endovenous Radiofrequency Ablation(RFA) Catheter in people with Varicose Veins of Lower Limb, run by Peking University People's Hospital at 1 site in China.
Trial summary
The purpose of this clinical trial is to evaluate the effectiveness and safety of Medical Adhesive produced by Beijing Compont Medical Devices Co., Ltd. in the treatment of varicose veins in the lower extremities. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Varicose Veins of Lower Limb
- What is being tested?
- Medical Adhesive and ClosureFast Endovenous Radiofrequency Ablation(RFA) Catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 188 participants
- Where
- 1 siteChina
- Study dates
- 11 Jan 2023to Dec 2024
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinically diagnosed as great saphenous vein varices. (This operation only dealt with one side varicose veins of the lower extremities.)
- CEAP is graded C2-C6.
- Doppler ultrasound confirmed the patency of deep veins of lower limbs.
- Sign informed consent, voluntarily participate in the trial and follow up as required
Who cannot join
- A history of lower extremity deep vein thrombosis or pulmonary embolism
- Recurrent varicose veins
- The diameter of target lesion of the great saphenous vein less than 2 mm or more than 15 mm
- The great saphenous vein is severely distorted or tuberculated at the root
- Sepsis or septicemia
- Allergic to n-butyl cyanoacrylate
Show all 11Show fewer
- The distance between the skin and the target vessel wall of the great saphenous vein less than 5 mm
- Severe cardiopulmonary disease, shock, coma or multiple organ failure
- Lactating or pregnant women
- Participated in other clinical trials within 1 month before surgery
- The researchers considered it unsuitable for inclusion
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Safety of Medical Adhesive in the Treatment of Varicose Veins of the Lower Extremities: A Prospective, Multicenter, Randomized Controlled Study
The purpose of this clinical trial is to evaluate the effectiveness and safety of Medical Adhesive produced by Beijing Compont Medical Devices Co., Ltd. in the treatment of varicose veins in the lower extremities.
The main questions it aims to answer is: What medical problems do participants have when using tissue glue? Researchers will compare Medical Adhesive to ClosureFast Endovenous Radiofrequency Ablation (RFA) Catheter (produced by Medtronic Inc. to see if Medical Adhesive works to treat varicose veins in the lower extremities.
Read more
Participants will:
Treated with closed varicose veins of the lower extremity by Medical Adhesive or ClosureFast.
Return to the hospital at 1, 12, and 24 weeks postoperatively for Doppler ultrasound, and at 4, 12, 24 weeks postoperatively for venous scoring.
- Conditions
- Varicose Veins of Lower Limb
- Being tested
- Medical Adhesive, ClosureFast Endovenous Radiofrequency Ablation(RFA) Catheter
- Keywords
- Varicose Veins of Lower Limb, NBCA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medical AdhesiveDevice
Medical Adhesive (produced by Beijing Compont Medical Devices Co., Ltd.) For varicose veins in the main saphenous vein, use 0.1 ml glue for every 3 cm of blood vessels.
ClosureFast Endovenous Radiofrequency Ablation(RFA) CatheterDevice
ClosureFast Endovenous Radiofrequency Ablation (RFA) Catheter (produced by America Medtronic Inc.) The ClosureFast catheter precisely heats a 7 cm vein segment in one 20-second interval.
| Study group | Role | What they receive |
|---|---|---|
| Medical Adhesive treatment group | Experimental | Not described Receives: Device: Medical Adhesive |
| Endovenous Radiofrequency Ablation Catheter | Active comparator | Not described Receives: Device: ClosureFast Endovenous Radiofrequency Ablation(RFA) Catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical success rate
At 24 weeks after surgery, Doppler ultrasound was used to check the closure of the target blood vessels.
Measured: 24 weeks after operation.
Secondary outcomes (7)
Technical success rate
Immediately after operation, Doppler ultrasound was used to check the closure of the target blood vessels.
Measured: Immediately after operation
Target vascular closure rate at 12 weeks after operation.
At 12 weeks after surgery, Doppler ultrasound was used to check the closure of the target blood vessels.
Measured: 12 weeks after operation.
Clinical signs
The severity of the patient's clinical presentation was assessed according to the Clinical signs- etiologic classification- anatomic distribution- pathophysiologic dysfunction classification (CEAP classification) criteria.
classification are as follows. C0: Without any visible or palpable signs of disease. C1: Telangiectasia or reticular veins C2: Varicose veins C2r: Recurrent varicose veins C3: Edema is present. C4: Changes in skin and subcutaneous tissue C4a: Pigmentation or eczema C4b: Lipodermatosclerosis or atrophie blanche C4c: Corona phlebectatica C5: Healed ulcers C6: Active ulcers C6r: Recurrent active venous ulcer
Measured: Screening period, 12 and 24 weeks after operation.
Venous Clinical Severity Score (VCSS)
The VCSS score ranges from 0 to 30, with a larger value indicating approximately severe symptoms.
Measured: Screening period, 4 weeks, 12 weeks and 24 weeks after operation.
Aberdeen Varicose Vein Questionnaire (AVVQ)
AVVQ scores range between 0 and 33, a higher score indicates a lower quality of life for patients.
Measured: Screening period, 4 weeks, 12 weeks and 24 weeks after operation.
Operation duration
Measured: Immediately after operation
Evaluation of product performance
The researchers evaluated the operation performance of the product from the aspects of ease of operation and injection function, and divided the evaluation into three levels: satisfactory, general and unsatisfactory.
Measured: within 24 hours after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2024
- Study start11 Jan 2023
- Primary completion3 Apr 2024
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Varicose Veins of Lower LimbStudies of the same condition, open and under way.
- More trials run by Peking University People's HospitalThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 188 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Peking University First Hospital, The Fourth Affiliated Hospital of Zhejiang University School of Medicine, First Affiliated Hospital Xi'an Jiaotong University, Liaocheng People's Hospital, The Second Affiliated Hospital of Chongqing Medical University
- Responsible party
- Principal investigator, Zhang Xiaoming, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06387264
- Sponsor's protocol ID
- 2022PHC032
- Status last verified
- Sep 2024
- First submitted
- 16 Apr 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Balint R, Farics A, Parti K, Vizsy L, Batorfi J, Menyhei G, Balint IB. Which endovenous ablation method does offer a better long-term technical success in the treatment of the incompetent great saphenous vein? Review. Vascular. 2016 Dec;24(6):649-657. doi: 10.1177/1708538116648035. Epub 2016 Apr 28.
PubMed 27126643Morrison N, Gibson K, McEnroe S, Goldman M, King T, Weiss R, Cher D, Jones A. Randomized trial comparing cyanoacrylate embolization and radiofrequency ablation for incompetent great saphenous veins (VeClose). J Vasc Surg. 2015 Apr;61(4):985-94. doi: 10.1016/j.jvs.2014.11.071. Epub 2015 Jan 31.
PubMed 25650040Morrison N, Gibson K, Vasquez M, Weiss R, Cher D, Madsen M, Jones A. VeClose trial 12-month outcomes of cyanoacrylate closure versus radiofrequency ablation for incompetent great saphenous veins. J Vasc Surg Venous Lymphat Disord. 2017 May;5(3):321-330. doi: 10.1016/j.jvsv.2016.12.005. Epub 2017 Mar 6.
PubMed 28411697Dimech AP, Cassar K. Efficacy of Cyanoacrylate Glue Ablation of Primary Truncal Varicose Veins Compared to Existing Endovenous Techniques: A Systematic Review of the Literature. Surg J (N Y). 2020 Jun 19;6(2):e77-e86. doi: 10.1055/s-0040-1708866. eCollection 2020 Apr.
PubMed 32577526Beteli CB, Rossi FH, de Almeida BL, Izukawa NM, Onofre Rossi CB, Gabriel SA, Kambara AM, de Moraes Rego Sousa AG, Thorpe P. Prospective, double-blind, randomized controlled trial comparing electrocoagulation and radiofrequency in the treatment of patients with great saphenous vein insufficiency and lower limb varicose veins. J Vasc Surg Venous Lymphat Disord. 2018 Mar;6(2):212-219. doi: 10.1016/j.jvsv.2017.09.010. Epub 2017 Dec 9.
PubMed 29229466Nordon IM, Hinchliffe RJ, Brar R, Moxey P, Black SA, Thompson MM, Loftus IM. A prospective double-blind randomized controlled trial of radiofrequency versus laser treatment of the great saphenous vein in patients with varicose veins. Ann Surg. 2011 Dec;254(6):876-81. doi: 10.1097/SLA.0b013e318230af5a.
PubMed 21934487
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Medical Adhesive in the Treatment of Varicose Veins of the Lower Extremities: A Prospective, Multicenter, Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06387264
- Acronym / sponsor ID
- 2022PHC032
- Conditions
- Varicose Veins of Lower Limb
- Keywords
- Varicose Veins of Lower Limb, NBCA
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 188 participants (actual)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Collaborators
- Peking University First Hospital, The Fourth Affiliated Hospital of Zhejiang University School of Medicine, First Affiliated Hospital Xi'an Jiaotong University, Liaocheng People's Hospital, The Second Affiliated Hospital of Chongqing Medical University
- Study start
- 11 Jan 2023 (actual)
- Primary completion
- 3 Apr 2024 (actual)
- Study completion
- Dec 2024 (estimated)
- First posted
- 29 Apr 2024 (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.
The purpose of this clinical trial is to evaluate the effectiveness and safety of Medical Adhesive produced by Beijing Compont Medical Devices Co., Ltd. in the treatment of varicose veins in the lower extremities.
The main questions it aims to answer is: What medical problems do participants have when using tissue glue? Researchers will compare Medical Adhesive to ClosureFast Endovenous Radiofrequency Ablation (RFA) Catheter (produced by Medtronic Inc. to see if Medical Adhesive works to treat varicose veins in the lower extremities.
Participants will:
Treated with closed varicose veins of the lower extremity by Medical Adhesive or ClosureFast.
Return to the hospital at 1, 12, and 24 weeks postoperatively for Doppler ultrasound, and at 4, 12, 24 weeks postoperatively for venous scoring.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Medical Adhesive treatment group | Experimental | Device: Medical Adhesive |
| Endovenous Radiofrequency Ablation Catheter | Active comparator | Device: ClosureFast Endovenous Radiofrequency Ablation(RFA) Catheter |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Clinically diagnosed as great saphenous vein varices. (This operation only dealt with one side varicose veins of the lower extremities.)
- CEAP is graded C2-C6.
- Doppler ultrasound confirmed the patency of deep veins of lower limbs.
- Sign informed consent, voluntarily participate in the trial and follow up as required
Key exclusion criteria (11 listed)
- A history of lower extremity deep vein thrombosis or pulmonary embolism
- Recurrent varicose veins
- The diameter of target lesion of the great saphenous vein less than 2 mm or more than 15 mm
- The great saphenous vein is severely distorted or tuberculated at the root
- Sepsis or septicemia
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 |
|---|---|---|
| Medical AdhesiveMedical Adhesive (produced by Beijing Compont Medical Devices Co., Ltd.) For varicose veins in the main saphenous vein, use 0.1 ml glue for every 3 cm of blood vessels. | Device | Medical Adhesive treatment group |
| ClosureFast Endovenous Radiofrequency Ablation(RFA) CatheterClosureFast Endovenous Radiofrequency Ablation (RFA) Catheter (produced by America Medtronic Inc.) The ClosureFast catheter precisely heats a 7 cm vein segment in one 20-second interval. | Device | Endovenous Radiofrequency Ablation Catheter |
Primary outcome
Clinical success rate
Time frame: 24 weeks after operation.
At 24 weeks after surgery, Doppler ultrasound was used to check the closure of the target blood vessels.
7 secondary outcomes
Technical success rate
Time frame: Immediately after operation
Target vascular closure rate at 12 weeks after operation.
Time frame: 12 weeks after operation.
Clinical signs
Time frame: Screening period, 12 and 24 weeks after operation.
Venous Clinical Severity Score (VCSS)
Time frame: Screening period, 4 weeks, 12 weeks and 24 weeks after operation.
Aberdeen Varicose Vein Questionnaire (AVVQ)
Time frame: Screening period, 4 weeks, 12 weeks and 24 weeks after operation.
Operation duration
Time frame: Immediately after operation
Evaluation of product performance
Time frame: within 24 hours after operation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Background: PubMed 27126643Balint R, Farics A, Parti K, Vizsy L, Batorfi J, Menyhei G, Balint IB. Which endovenous ablation method does offer a better long-term technical success in the treatment of the incompetent great saphenous vein? Review. Vascular. 2016 Dec;24(6):649-657. doi: 10.1177/1708538116648035. Epub 2016 Apr 28.
- Background: PubMed 25650040Morrison N, Gibson K, McEnroe S, Goldman M, King T, Weiss R, Cher D, Jones A. Randomized trial comparing cyanoacrylate embolization and radiofrequency ablation for incompetent great saphenous veins (VeClose). J Vasc Surg. 2015 Apr;61(4):985-94. doi: 10.1016/j.jvs.2014.11.071. Epub 2015 Jan 31.
- Background: PubMed 28411697Morrison N, Gibson K, Vasquez M, Weiss R, Cher D, Madsen M, Jones A. VeClose trial 12-month outcomes of cyanoacrylate closure versus radiofrequency ablation for incompetent great saphenous veins. J Vasc Surg Venous Lymphat Disord. 2017 May;5(3):321-330. doi: 10.1016/j.jvsv.2016.12.005. Epub 2017 Mar 6.
- Background: PubMed 32577526Dimech AP, Cassar K. Efficacy of Cyanoacrylate Glue Ablation of Primary Truncal Varicose Veins Compared to Existing Endovenous Techniques: A Systematic Review of the Literature. Surg J (N Y). 2020 Jun 19;6(2):e77-e86. doi: 10.1055/s-0040-1708866. eCollection 2020 Apr.
- Background: PubMed 29229466Beteli CB, Rossi FH, de Almeida BL, Izukawa NM, Onofre Rossi CB, Gabriel SA, Kambara AM, de Moraes Rego Sousa AG, Thorpe P. Prospective, double-blind, randomized controlled trial comparing electrocoagulation and radiofrequency in the treatment of patients with great saphenous vein insufficiency and lower limb varicose veins. J Vasc Surg Venous Lymphat Disord. 2018 Mar;6(2):212-219. doi: 10.1016/j.jvsv.2017.09.010. Epub 2017 Dec 9.
- Background: PubMed 21934487Nordon IM, Hinchliffe RJ, Brar R, Moxey P, Black SA, Thompson MM, Loftus IM. A prospective double-blind randomized controlled trial of radiofrequency versus laser treatment of the great saphenous vein in patients with varicose veins. Ann Surg. 2011 Dec;254(6):876-81. doi: 10.1097/SLA.0b013e318230af5a.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Medical Adhesive and ClosureFast Endovenous Radiofrequency Ablation(RFA) Catheter in people with Varicose Veins of Lower Limb, run by Peking University People's Hospital at 1 site in China.
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 4 inclusion and 11 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 19 Sep 2024. 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 China. 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?
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?
Clinical success rate (time frame: 24 weeks after operation.). 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 NCT06387264, which also lists 6 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 19 Sep 2024.