Efficacy and safety of polyvinylalcohol (Pol-RRB--based foam versus conventional foam in the treatment of venous malformations of the head and neck (VMs) : a prospective, randomized, controlled study

Status

Recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2500103007

Enrollment

Unknown

Registered

2025-05-22

Start date

2025-01-21

Completion date

Unknown

Last updated

2025-05-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Venous malformation of head and neck

Interventions

Test group:ADD 0.1 ml 0.05% ha (20mg/2ML, shipeite, Shandong Zhengda Frida pharmaceutical company, Shandong China)

Control group:NOT ADD 0.1 ml 0.05% ha (20mg/2ML, shipeite, Shandong Zhengda Frida pharmaceutical company, Shandong China)

Eligibility

Sex/Gender

All

Age

14 Years to 60 Years

Inclusion 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

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

Design outcomes

Primary

Measure	Time frame
Volume change of venous malformation before and after treatment;Remission rate of venous malformations in head and neck;	—

Secondary

Measure	Time frame
Complications;Amount of hardened foam injected;Patient satisfaction;Number of treatment;	—

Countries

China

Contacts

Public Contactshaohualiu

Shandong University Qilu Hospital

lshabccba@126.com+86 185 6008 3730

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026