Venous MalformationNCT07066527
Efficacy and Safety Analysis of Polylauric Alcohol More Stable Foam Versus Ordinary Foam in the Treatment of Head and Neck Venous Malformations
A study testing The addition of sodium hyaluronate to poly (cinnamyl alcohol-RRB- produces a more stable foam in people with Venous Malformation, run by Qilu Hospital of Shandong University at 1 site in China.
Trial summary
The aim of this study is to explore the efficacy and safety of poly -LRB-cinnamyl alcohol) foam in the treatment of venous malformations of head and neck through a prospective randomized clinical trial, this trial may provide better treatment options and evidence for head and neck VMs. Read more about this study
- Who is it for?
- Ages 14 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Venous Malformation
- What is being tested?
- The addition of sodium hyaluronate to poly (cinnamyl alcohol-RRB- produces a more stable foam
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2022to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 14 to 60 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Age 14-60 years of age, sex unlimited (except pregnant women or those preparing for pregnancy)
- Clinical diagnosis and imaging () were consistent with head and neck venous malformations
- Participants volunteered to participate in the trial and signed an informed consent form.
Who cannot join
- People with serious systemic diseases, including heart disease, high blood pressure, diabetes, etc. , that are not under control. Heart Attack: 1. Recent frequent attacks of angina. 2. Recent history of myocardial infarction 3. Cardiac function grade iii-iv or with symptoms of sitting breathing, cyanosis, jugular venous distension, lower limb edema, etc. . 4. Heart disease complicated with hypertension 5. Type II or III Type II atrioventricular block, double bundle branch block, as syndrome, diabetes: blood sugar control in 8.88 mmol/L above, hypertension: after taking medicine blood pressure can not be controlled in the normal range namely systolic pressure below 140 mmhg, diastolic pressure below 90 mmhg)
- Patients who are unable to follow up on time;
- Persons who are mentally ill or have mental disorders;
- The patient or his/her authorized person is unwilling to sign a written informed consent or comply with the protocol
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shandong University Qilu Hospital
Jinan, Shandong, 250000
shaohua liu, PhD, +86 185 6008 3730, lshabccba@126.com
About this study
Official title: Efficacy and Safety Analysis of More Stable Foam and Ordinary Foam Based on Polylauricol in the Treatment of Head and Neck Venous Malformations: a Prospective, Randomized and Controlled Study
The aim of this study is to explore the efficacy and safety of poly -LRB-cinnamyl alcohol) foam in the treatment of venous malformations of head and neck through a prospective randomized clinical trial, this trial may provide better treatment options and evidence for head and neck VMs.
Read the detailed description
Foam sclerotherapy is an effective method for the treatment of venous malformations in head and neck, which has been widely used in the world in recent years. The foam hardener is a kind of uniform microfoam formed by the mixture of surfactant liquid hardener and a certain proportion of gas. The microfoam has fluidity and can be injected into the cavity of venous malformation, the foam can replace the blood in the Lacuna, and can expel the blood, the foam occupies the lesion lacuna, makes the hardener be diluted by the blood to the minimum degree, so that the function concentration of the hardener can be guaranteed, the foam can contact the endothelial cells of venous malformations, acting as the contact betthe investigatorsen the liquid hardener and the endothelial cells, and the foam is less mobile than the liquid hardener, so the foam can be replaced by the blood for a longer time than the liquid hardener, sclerosants can affect endothelial cells for a long time. The disadvantage of liquid hardeners is that they are diluted by blood, leading to an insufficient level of desired effect at the injection site and into the normal venous system. In contrast, foam hardeners replace blood rather than mix with it and occupy the interior of blood vessels. The foam blocks blood flow, increasing the time of contact betthe investigatorsen the Hardener and the vessel wall. Foam hardeners are more effective than liquid hardeners in treating VMS. There are many factors that affect the therapeutic effect of foam hardening, such as the types of hardeners and the stability of foam, among which the stability of foam is one of the key factors that affect the therapeutic effect of foam hardening, the stability of the foam is affected by many factors, such as the type, concentration, liquid-gas ratio, gas type and temperature of the Hardener. The half-life, the time it takes for a foam to reduce its volume to half its original volume (half-volume) , is widely used to assess foam stability. According to the study, the half-life of 1% poly (cinnamyl alcohol-RPol(POL) foam with a liquid-to-gas ratio of 1:4 was 142.8(64.32) seconds, in this study, the half-life of the foam made from 1% POL containing 0.05% hyaluronic acid (HA) was 390.4(613.06) seconds, human blood contains a certain amount of HA, according to the literature reported that 0.05% concentration of HA injected into human blood is safe, so this more stable foam preparation method was patented, and published in international journals. Our team used more stable POL foam to treat head and neck VMs, which was found to be safe and effective by retrospective study. The results of this study have been published in international journal. It has also been reported that glycerol added to the sclerosing agent polydocanol or sodium tetradecyl sulfate can enhance the stability of the foam. The foam produced by glycerol has been used in the treatment of VMS of the head and neck for more than 2 years, and that a more stable bubble might work better. Therefore, whether the more stable hardening agent foam will have better therapeutic effect and whether its safety is different from that of ordinary foam, there is only conjecture and no clear evidence to ansthe investigatorsr this question. Therefore, on the basis of the previous research, a prospective randomized clinical trial was conducted to evaluate the efficacy and safety of polycinol foam in the treatment of venous malformations in the head and neck region, this trial may provide better treatment options and evidence for head and neck VMs.
- Conditions
- Venous Malformation
- Being tested
- The addition of sodium hyaluronate to poly (cinnamyl alcohol-RRB- produces a more stable foam
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The addition of sodium hyaluronate to poly (cinnamyl alcohol-RRB- produces a more stable foamCombination product
According to the study, the half-life of 1% poly (cinnamyl alcohol-RPol(POL) foam with a liquid-to-gas ratio of 1:4 was 142.8(64.32) seconds, in this study, the half-life of the foam made from 1% POL containing 0.05% hyaluronic acid (HA) was 390.4(613.06) seconds, human blood contains a certain amount of HA, according to the literature reported that 0.05% concentration of HA injected into human blood is safe, so this more stable foam preparation method was patented, and published in international journals.
| Study group | Role | What they receive |
|---|---|---|
| A common foam prepared from poly (cinnamyl alcohol) | No intervention | 1% POL solution 2ml + 8ml air was used to produce foam by Tessari's method for head and neck VMs |
| More stable foams made from poly -LRB-cinnamyl alcohol) | Active comparator | 0.05% 0.1 ml hyaluronic acid+1% POL solution 2ml + 8ml air was used to produce foam by Tessari's method for head and neck VMs Receives: Combination Product: The addition of sodium hyaluronate to poly (cinnamyl alcohol-RRB- produces a more stable foam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Remission rate of venous malformations in head and neck
Patients were satisfied and no further treatment was needed after clinical evaluation. This was the last treatment. The proportion of patients who responded to treatment was counted and compared between the two groups.
Measured: 3-4 weeks after treatment
Secondary outcomes (3)
Volume of venous malformation
The volume changes of venous malformations were compared before and after treatment. The patients were examined by MRI before operation and after the last treatment
Measured: 3-4 weeks after treatment
Foam injection
The total foam volume from the first treatment to the end of treatment was recorded.
Measured: 3-4 weeks after treatment
Number of treatment
Statistics of patients with the first treatment to the last treatment of the total number of treatments.
Measured: According to the condition whether need to be treated again, is generally 3-4 weeks for a treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2025
- Study start1 Jun 2022
- Primary completion30 Dec 2025 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venous MalformationStudies of the same condition, open and under way.
- More trials run by Qilu Hospital of Shandong UniversityThe 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qilu Hospital of Shandong University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- shaohua liu, Doctoral, Principal investigator, Shandong University Qilu Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07066527
- Sponsor's protocol ID
- KYLL-202207-006-2
- Status last verified
- May 2025
- First submitted
- 20 Mar 2025
- Last updated
- 15 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety Analysis of More Stable Foam and Ordinary Foam Based on Polylauricol in the Treatment of Head and Neck Venous Malformations: a Prospective, Randomized and Controlled Study
- ClinicalTrials.gov ID
- NCT07066527
- Acronym / sponsor ID
- KYLL-202207-006-2
- Conditions
- Venous Malformation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Qilu Hospital of Shandong UniversityUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 15 Jul 2025 (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 aim of this study is to explore the efficacy and safety of poly -LRB-cinnamyl alcohol) foam in the treatment of venous malformations of head and neck through a prospective randomized clinical trial, this trial may provide better treatment options and evidence for head and neck VMs.
Detailed description
Foam sclerotherapy is an effective method for the treatment of venous malformations in head and neck, which has been widely used in the world in recent years. The foam hardener is a kind of uniform microfoam formed by the mixture of surfactant liquid hardener and a certain proportion of gas. The microfoam has fluidity and can be injected into the cavity of venous malformation, the foam can replace the blood in the Lacuna, and can expel the blood, the foam occupies the lesion lacuna, makes the hardener be diluted by the blood to the minimum degree, so that the function concentration of the hardener can be guaranteed, the foam can contact the endothelial cells of venous malformations, acting as the contact betthe investigatorsen the liquid hardener and the endothelial cells, and the foam is less mobile than the liquid hardener, so the foam can be replaced by the blood for a longer time than the liquid hardener, sclerosants can affect endothelial cells for a long time. The disadvantage of liquid hardeners is that they are diluted by blood, leading to an insufficient level of desired effect at the injection site and into the normal venous system. In contrast, foam hardeners replace blood rather than mix with it and occupy the interior of blood vessels. The foam blocks blood flow, increasing the time of contact betthe investigatorsen the Hardener and the vessel wall. Foam hardeners are more effective than liquid hardeners in treating VMS. There are many factors that affect the therapeutic effect of foam hardening, such as the types of hardeners and the stability of foam, among which the stability of foam is one of the key factors that affect the therapeutic effect of foam hardening, the stability of the foam is affected by many factors, such as the type, concentration, liquid-gas ratio, gas type and temperature of the Hardener. The half-life, the time it takes for a foam to reduce its volume to half its original volume (half-volume) , is widely used to assess foam stability. According to the study, the half-life of 1% poly (cinnamyl alcohol-RPol(POL) foam with a liquid-to-gas ratio of 1:4 was 142.8(64.32) seconds, in this study, the half-life of the foam made from 1% POL containing 0.05% hyaluronic acid (HA) was 390.4(613.06) seconds, human blood contains a certain amount of HA, according to the literature reported that 0.05% concentration of HA injected into human blood is safe, so this more stable foam preparation method was patented, and published in international journals. Our team used more stable POL foam to treat head and neck VMs, which was found to be safe and effective by retrospective study. The results of this study have been published in international journal. It has also been reported that glycerol added to the sclerosing agent polydocanol or sodium tetradecyl sulfate can enhance the stability of the foam. The foam produced by glycerol has been used in the treatment of VMS of the head and neck for more than 2 years, and that a more stable bubble might work better. Therefore, whether the more stable hardening agent foam will have better therapeutic effect and whether its safety is different from that of ordinary foam, there is only conjecture and no clear evidence to ansthe investigatorsr this question. Therefore, on the basis of the previous research, a prospective randomized clinical trial was conducted to evaluate the efficacy and safety of polycinol foam in the treatment of venous malformations in the head and neck region, this trial may provide better treatment options and evidence for head and neck VMs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A common foam prepared from poly (cinnamyl alcohol) | No intervention | –1% POL solution 2ml + 8ml air was used to produce foam by Tessari's method for head and neck VMs |
| More stable foams made from poly -LRB-cinnamyl alcohol) | Active comparator | Combination Product: The addition of sodium hyaluronate to poly (cinnamyl alcohol-RRB- produces a more stable foam0.05% 0.1 ml hyaluronic acid+1% POL solution 2ml + 8ml air was used to produce foam by Tessari's method for head and neck VMs |
Who may qualify
- Ages
- 14 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Age 14-60 years of age, sex unlimited (except pregnant women or those preparing for pregnancy)
- Clinical diagnosis and imaging () were consistent with head and neck venous malformations
- Participants volunteered to participate in the trial and signed an informed consent form.
Key exclusion criteria (4 listed)
- People with serious systemic diseases, including heart disease, high blood pressure, diabetes, etc. , that are not under control. Heart Attack: 1. Recent frequent attacks of angina. 2. Recent history of myocardial infarction 3. Cardiac function grade iii-iv or with symptoms of sitting breathing, cyanosis, jugular venous distension, lower limb edema, etc. . 4. Heart disease complicated with hypertension 5. Type II or III Type II atrioventricular block, double bundle branch block, as syndrome, diabetes: blood sugar control in 8.88 mmol/L above, hypertension: after taking medicine blood pressure can not be controlled in the normal range namely systolic pressure below 140 mmhg, diastolic pressure below 90 mmhg)
- Patients who are unable to follow up on time;
- Persons who are mentally ill or have mental disorders;
- The patient or his/her authorized person is unwilling to sign a written informed consent or comply with the protocol
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 |
|---|---|---|
| The addition of sodium hyaluronate to poly (cinnamyl alcohol-RRB- produces a more stable foamAccording to the study, the half-life of 1% poly (cinnamyl alcohol-RPol(POL) foam with a liquid-to-gas ratio of 1:4 was 142.8(64.32) seconds, in this study, the half-life of the foam made from 1% POL containing 0.05% hyaluronic acid (HA) was 390.4(613.06) seconds, human blood contains a certain amount of HA, according to the literature reported that 0.05% concentration of HA injected into human blood is safe, so this more stable foam preparation method was patented, and published in international journals. | Combination product | More stable foams made from poly -LRB-cinnamyl alcohol) |
Primary outcome
Remission rate of venous malformations in head and neck
Time frame: 3-4 weeks after treatment
Patients were satisfied and no further treatment was needed after clinical evaluation. This was the last treatment. The proportion of patients who responded to treatment was counted and compared between the two groups.
3 secondary outcomes
Volume of venous malformation
Time frame: 3-4 weeks after treatment
Foam injection
Time frame: 3-4 weeks after treatment
Number of treatment
Time frame: According to the condition whether need to be treated again, is generally 3-4 weeks for a treatment.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2025.
- 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.
shaohua liu, Doctoral principal investigator
Shandong University Qilu Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The addition of sodium hyaluronate to poly (cinnamyl alcohol-RRB- produces a more stable foam in people with Venous Malformation, run by Qilu Hospital of Shandong University 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 3 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 15 Jul 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact shaohua liu, Doctoral (+8618560083730, lshabccba@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Remission rate of venous malformations in head and neck (time frame: 3-4 weeks after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Jul 2025.