NCT04930952

Brief Summary

The aim of this study is to clarify complications of Ethanolamine Oleate intralesional injections of maxillofacial venous formations in pediatric patients

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 28, 2019

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2021

Completed
3 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 3, 2021

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 11, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 18, 2021

Completed
Last Updated

June 18, 2021

Status Verified

June 1, 2021

Enrollment Period

2 years

First QC Date

June 11, 2021

Last Update Submit

June 11, 2021

Conditions

Venous Malformation

Keywords

MaxillofacialPediatricVenous MalformationsEthanol-amine Oleate

Outcome Measures

Primary Outcomes (1)

  • Clinical Response

    Complete Response - Marked Improvement - Moderate Improvement - No Response

    12 months

Interventions

Ethanol-amine Oleate Sclerotherapy InjectionDRUG

Intralesional Sclerotherapy Injection

Also known as: Sclerotherapy

Eligibility Criteria

AgeUp to 12 Years
Sexall
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Suez Canal University

Ismailia, Egypt

Location

MeSH Terms

Interventions

Sclerotherapy

Intervention Hierarchy (Ancestors)

Drug TherapyTherapeutics

Study Officials

  • Sarah Arafat, MSc

    Assistant Lecturer

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Target Duration
12 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Lecturer

Study Record Dates

First Submitted

June 11, 2021

First Posted

June 18, 2021

Study Start

February 28, 2019

Primary Completion

February 28, 2021

Study Completion

March 3, 2021

Last Updated

June 18, 2021

Record last verified: 2021-06

Locations

EG(1)