Complications of Ethanol-amine Oleate Intralesional Scler... | NCT04930952

Studies
Complications of Ethanol-amine Oleate Intralesional Sclerotherapy

NCT04930952

Sponsor

Suez Canal University

Status

Completed

Last Update Posted

May 13, 2026Actual

Enrollment

15Actual

Phase

Not provided

Conditions

Venous Malformation

Interventions

Ethanol-amine Oleate Sclerotherapy Injection

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 28, 2019Actual

Primary Completion Date

Feb 28, 2021Actual

Completion Date

Mar 3, 2021Actual

First Submitted Date

Jun 11, 2021

First Submission Date that Met QC Criteria

Jun 11, 2021

First Posted Date

Jun 18, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 8, 2026

Last Update Posted Date

May 13, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

12 Months

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

15Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ethanol-amine Oleate Sclerotherapy Injection	Drug	Intralesional Sclerotherapy Injection		Sclerotherapy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Clinical Response	Complete Response - Marked Improvement - Moderate Improvement - No Response	12 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria: maxillofacial venous malformation

Exclusion Criteria:

Patients with lung, liver, or kidney diseases
Patients with Klippel-Trenaunay syndrome
Patients mental or physical disabilities

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

12 Years

Standard Ages

Child

Study Population

Pediatric patients of age up to 12 years having maxillofacial venous malformations

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Sarah Arafat, MSc	Assistant Lecturer	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Suez Canal University		Ismailia			Egypt

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D015911	Sclerotherapy

Ancestor Terms

ID	Term
D004358	Drug Therapy
D013812	Therapeutics

Browse Leaves

Not provided

Browse Branches

Not provided