Complications of Ethanol-amine Oleate Intralesional Sclerotherapy
May 8, 2026 updated by: Sarah Arafat, Suez Canal University
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
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Observational
Enrollment (Actual)
15
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Ismailia, Egypt
- Suez Canal University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
No older than 12 years (Child)
Accepts Healthy Volunteers
Yes
Sampling Method
Probability Sample
Study Population
Pediatric patients of age up to 12 years having maxillofacial venous malformations
Description
Inclusion Criteria: maxillofacial venous malformation
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Exclusion Criteria:
- Patients with lung, liver, or kidney diseases
- Patients with Klippel-Trenaunay syndrome
- Patients mental or physical disabilities
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Other
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Clinical Response
Time Frame: 12 months
|
Complete Response - Marked Improvement - Moderate Improvement - No Response
|
12 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Sarah Arafat, MSc, assistant lecturer
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 28, 2019
Primary Completion (Actual)
February 28, 2021
Study Completion (Actual)
March 3, 2021
Study Registration Dates
First Submitted
June 11, 2021
First Submitted That Met QC Criteria
June 11, 2021
First Posted (Actual)
June 18, 2021
Study Record Updates
Last Update Posted (Actual)
May 13, 2026
Last Update Submitted That Met QC Criteria
May 8, 2026
Last Verified
June 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 157-2018
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.