Venous MalformationNCT04930952
Complications of Ethanol-amine Oleate Intralesional Sclerotherapy
An observational study of Venous Malformation, run by Suez Canal University at 1 site in Egypt.
Trial summary
The aim of this study is to clarify complications of Ethanolamine Oleate intralesional injections of maxillofacial venous formations in pediatric patients Read more about this study
- Who is it for?
- Ages Up to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Venous Malformation
- What is being tested?
- Ethanol-amine Oleate Sclerotherapy Injection
- Type of treatment
- Injection or infusion
- How many people
- 15 participants
- Where
- 1 siteEgypt
- Study dates
- 28 Feb 2019to 3 Mar 2021
- How long will I take part?
- 12 Months
- 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 Up to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Pediatric patients of age up to 12 years having maxillofacial venous malformations
Who may be able to join
- -
Who cannot join
- Patients with lung, liver, or kidney diseases
- Patients with Klippel-Trenaunay syndrome
- Patients mental or physical disabilities
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Complications of Ethanol-amine Oleate Intralesional Sclerotherapy Injections of Maxillofacial Venous Malformations in Pediatric Patients
The aim of this study is to clarify complications of Ethanolamine Oleate intralesional injections of maxillofacial venous formations in pediatric patients
Read the detailed description
Maxillofacial Venous malformations cause many functional and esthetic complications in children, intralesional sclerotherapy is the best choice of treatment; and Ethanol-amine Oleate has been the most commonly used sclerosing agent.
The aim of this study is to clarify complications of Ethanolamine Oleate intralesional injections of maxillofacial venous formations
- Conditions
- Venous Malformation
- Being tested
- Ethanol-amine Oleate Sclerotherapy Injection
- Keywords
- Maxillofacial, Pediatric, Venous Malformations, Ethanol-amine Oleate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ethanol-amine Oleate Sclerotherapy InjectionDrug
Also called Sclerotherapy
Intralesional Sclerotherapy Injection
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Response
Complete Response - Marked Improvement - Moderate Improvement - No Response
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2021
- Study start28 Feb 2019
- Primary completion28 Feb 2021
- Study completion3 Mar 2021
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 Suez Canal 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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 15 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Suez Canal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sarah Arafat, Suez Canal University
- Investigators
- Sarah Arafat, MSc, Principal investigator, Assistant Lecturer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04930952
- Sponsor's protocol ID
- 157-2018
- Status last verified
- Jun 2021
- First submitted
- 11 Jun 2021
- Last updated
- 13 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Complications of Ethanol-amine Oleate Intralesional Sclerotherapy Injections of Maxillofacial Venous Malformations in Pediatric Patients
- ClinicalTrials.gov ID
- NCT04930952
- Acronym / sponsor ID
- 157-2018
- Conditions
- Venous Malformation
- Keywords
- Maxillofacial, Pediatric, Venous Malformations, Ethanol-amine Oleate
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Suez Canal UniversityUniversity, hospital or other
- Study start
- 28 Feb 2019 (actual)
- Primary completion
- 28 Feb 2021 (actual)
- Study completion
- 3 Mar 2021 (actual)
- First posted
- 18 Jun 2021 (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 clarify complications of Ethanolamine Oleate intralesional injections of maxillofacial venous formations in pediatric patients
Detailed description
Maxillofacial Venous malformations cause many functional and esthetic complications in children, intralesional sclerotherapy is the best choice of treatment; and Ethanol-amine Oleate has been the most commonly used sclerosing agent.
The aim of this study is to clarify complications of Ethanolamine Oleate intralesional injections of maxillofacial venous formations
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 12 Months
Who may qualify
- Ages
- Up to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Pediatric patients of age up to 12 years having maxillofacial venous malformations
Key inclusion criteria (1 listed)
- -
Key exclusion criteria (3 listed)
- Patients with lung, liver, or kidney diseases
- Patients with Klippel-Trenaunay syndrome
- Patients mental or physical disabilities
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 |
|---|---|---|
| Ethanol-amine Oleate Sclerotherapy InjectionAlso: SclerotherapyIntralesional Sclerotherapy Injection | Drug | – |
Primary outcome
Clinical Response
Time frame: 12 months
Complete Response - Marked Improvement - Moderate Improvement - No Response
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2026.
- Individual participant dataSharing planned: Undecided
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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.
Sarah Arafat, MSc principal investigator
Assistant Lecturer
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 Venous Malformation, run by Suez Canal University at 1 site in Egypt.
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 1 inclusion and 3 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: finished, as of the sponsor's last update on 13 May 2026. 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 Egypt. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 Response (time frame: 12 months). 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 13 May 2026.