Sodium hyaluronate–stabilized poly(cinnamyl alcohol) foam versus ordinary foam for head and neck venous malformations
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
Run by Qilu Hospital of Shandong University · NCT07066527 · Data updated 2026-11-12
This trial will test whether a sodium hyaluronate–stabilized poly(cinnamyl alcohol) foam works better and is safer than ordinary foam for people aged 14–60 with head and neck venous malformations.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 14 Years to 60 Years |
| Sex | All |
| Enrollment | 110 (estimated) |
| Sponsor | Qilu Hospital of Shandong University Academic / other |
| Locations | 1 site (Jinan, Shandong) |
| Status | Recruiting |
| Started | June 1, 2022 |
| Main results expected | December 30, 2025 |
| Study ends | June 30, 2026 |
| Registry record updated | July 15, 2025 |
| Trial ID | NCT07066527 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are patients aged 14–60 with imaging-confirmed head and neck venous malformations who are medically fit, not pregnant, and able to provide informed consent and attend follow-up at Qilu Hospital.
✕Probably not a fit
Patients with uncontrolled serious systemic diseases, significant cardiac conduction or function problems, poorly controlled diabetes, pregnant women, or those with non-venous vascular lesions are unlikely to benefit or may be excluded.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This single-center, prospective randomized trial at Qilu Hospital compares a sodium hyaluronate–stabilized poly(cinnamyl alcohol) microfoam with standard foam sclerotherapy for venous malformations of the head and neck. Eligible patients aged 14–60 with imaging-confirmed head and neck venous malformations are randomized to receive injections of the stabilized foam or ordinary foam into lesion lacunae under image guidance. The stabilized foam is intended to displace blood, prolong sclerosant contact with the endothelium, and reduce dilution compared with liquid agents, and outcomes include lesion size reduction, symptom relief, and adverse events. Patients are followed at predefined intervals to compare efficacy, recurrence, and safety between the two foam preparations.
Why it matters
Potential benefit: If successful, the stabilized foam could improve lesion control and reduce recurrence or complications compared with ordinary foam sclerotherapy.
How similar studies have gone: Foam sclerotherapy has been shown to be more effective than liquid sclerosants in prior work, but adding sodium hyaluronate to stabilize poly(cinnamyl alcohol) foam is a relatively novel modification with limited published clinical data.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age 14-60 years of age, sex unlimited (except pregnant women or those preparing for pregnancy) 2. Clinical diagnosis and imaging () were consistent with head and neck venous malformations 3. Participants volunteered to participate in the trial and signed an informed consent form. Exclusion Criteria: 1. 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) 2. Patients who are unable to follow up on time; 3. Persons who are mentally ill or have mental disorders; 4. The patient or his/her authorized person is unwilling to sign a written informed consent or comply with the protocol
Where it's running
-
Shandong University Qilu Hospital
Jinan, Shandong, China Recruiting
Study contacts
- Principal investigator: shaohua liu, Doctoral — Shandong University Qilu Hospital
- Study coordinator: shaohua liu, Doctoral
- Email: lshabccba@126.com
- Phone: +8618560083730
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.